Medical Device Manufacturer · US , Mchenry , IL

Warner-Lambert Co.

50 submissions · 50 cleared · Since 1979
50
Total
50
Cleared
0
Denied

Warner-Lambert Co. — FDA 510(k) Submissions

Warner-Lambert Co. has submitted 50 FDA 510(k) premarket notifications since 1979, of which 50 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days, Susceptibility Test Discs, Antimicrobial, Multi-analyte Controls, All Kinds (assayed), Agglutination Method, Human Chorionic Gonadotropin, Light Source, Photographic, Fiberoptic . Use the specialty filter in the sidebar to narrow results.

50 devices
1–25 of 50
NEOSPORIN SCAR SOLUTION
K024160 · MDA Elastomer, Silicone, For... · General & Plastic Surgery
Mar 2003 90d
EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAM
K893452 · IZZ Table, Radiographic,... · Radiology
Jun 1989 50d
O.P.T.(TM) OVULATION PREDICTION TEST
K870584 · CEP Radioimmunoassay,... · Chemistry
Nov 1987 287d
MULTILUMEN VIAPIC CENTRAL LINE CATHETER
K861510 · FOZ Catheter, Intravascular,... · General Hospital
Jun 1986 47d
GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK
K852689 · JTN Susceptibility Test... · Microbiology
Aug 1985 55d
GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISK
K852967 · JTN Susceptibility Test... · Microbiology
Aug 1985 35d
GENERAL DIAGNOSTICS COAG-A-MATE XC
K852843 · KQC Stains, Hematology · Hematology
Aug 1985 39d
GENERAL DIAGNOSTICS RAPID E. COLI TEST
K852889 · JTO Discs, Strips And... · Microbiology
Jul 1985 14d
GEN. DIAG. CHROMOSTRATE REF. PLASMA
K850409 · JPA System, Multipurpose For... · Hematology
May 1985 93d
GEN. DIAG. CHROMOSTRATE PLASMINOGEN ASSAY
K850410 · DDX Plasminogen, Antigen,... · Immunology
May 1985 93d
GEN. DIAG. CHROMOSTRATE ALPHA-2 ANTIPLASMIN ASSAY
K850411 · LGP Assay, Alpha-2-antiplasmin · Immunology
May 1985 93d
GEN. DIAG. CHROMOSTRATE ANTITHROMBIN III ASSAY
K850412 · JBQ Antithrombin Iii... · Hematology
May 1985 93d
GENERAL DIAG. CHROMOSTRATE HEPARIN ASSAY
K850486 · KFF Assay, Heparin · Hematology
May 1985 90d
GENERAL DIAGNOSTICS TICARCILLIN 75MCG SUSCEPT-DISK
K850957 · JTN Susceptibility Test... · Microbiology
May 1985 54d
GENERAL DIAGNOSTICS AUGMENTIN 30MCG SUSCEP DISK
K851228 · JTN Susceptibility Test... · Microbiology
Apr 1985 29d
EARLY DETECTOR
K833369 · KHE Reagent, Occult Blood · Hematology
Aug 1984 310d
VANISH II
K833093 · KGO Surgeon's Gloves · General Hospital
Dec 1983 91d
DESERET SUBCLAVIAN JUGULAR CATH-SET
K833091 · FOZ Catheter, Intravascular,... · General Hospital
Nov 1983 70d
DESERET ANGIO-GUIDE LARGE VEIN CATH.
K833092 · FOZ Catheter, Intravascular,... · General Hospital
Nov 1983 70d
GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL
K833352 · GIL Plasma, Fibrinogen Control · Hematology
Nov 1983 36d
EARLY IN HOME PREGNANCY TEST
K832599 · JHJ Agglutination Method,... · Chemistry
Sep 1983 49d
E.P.T. PLUS TM
K831535 · JHJ Agglutination Method,... · Chemistry
Jun 1983 48d
ENSURE DRESSING
K830593 · NAD Dressing, Wound, Occlusive · General & Plastic Surgery
Apr 1983 41d
AO DOCUSTAR(MMIRO) FUNDUS CAMERA
K822991 · HKI Camera, Ophthalmic,... · Ophthalmic
Feb 1983 135d
DESERET ARTERIAL BLOOD SAMPLING KIT
K822248 · CBT Arterial Blood Sampling Kit · Anesthesiology
Oct 1982 84d
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