Medical Device Manufacturer · US , Austin , TX

Consolidated Technologies, Inc.

20 submissions · 20 cleared · Since 1991
20
Total
20
Cleared
0
Denied

Consolidated Technologies, Inc. — FDA 510(k) Submissions

Consolidated Technologies, Inc. has submitted 20 FDA 510(k) premarket notifications since 1991, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Multi-analyte Controls, All Kinds (assayed), Urinalysis Controls (assayed And Unassayed), Drug Specific Control Materials, System, Test, Rheumatoid Factor, System, Test, Infectious Mononucleosis . Use the specialty filter in the sidebar to narrow results.

20 devices
1–20 of 20
QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 AND 3
K000116 · JJY Multi-analyte Controls,... · Chemistry
Feb 2000 32d
URINE CHEMISTRY CONTROL, LEVEL 1
K992576 · JJW Urinalysis Controls... · Chemistry
Sep 1999 32d
URINE CHEMISTRY CONTROL, LEVEL 2
K992578 · JJW Urinalysis Controls... · Chemistry
Sep 1999 32d
REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE
K992151 · LAS Drug Specific Control... · Toxicology
Jul 1999 20d
QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3
K981339 · JJY Multi-analyte Controls,... · Chemistry
Apr 1998 8d
REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE
K974699 · DKB Calibrators, Drug Mixture · Toxicology
Jan 1998 37d
QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM UNASSAYED LIQUID CHEMISTRY CONTROL LEVELS
K973469 · JJY Multi-analyte Controls,... · Chemistry
Sep 1997 21d
QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGATIVE CONTROLS
K972146 · LYR Helicobacter Pylori · Microbiology
Jul 1997 29d
QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMANCEE MCC-LIGAND CONTROL LEVELS 1, 2 AND 3
K972080 · JJY Multi-analyte Controls,... · Chemistry
Jun 1997 15d
QUALITROL ANA CONTROL SERUM SET
K961815 · LKJ Antinuclear Antibody,... · Immunology
Sep 1996 140d
QUALITROL IGAME CONTROLS, LEVELS 1 AND 2
K961544 · DGR Whole Human Serum,... · Immunology
Sep 1996 155d
QUALITROL RF CONTROLS
K961545 · DHR System, Test, Rheumatoid... · Immunology
Sep 1996 155d
QUALITROL MONO CONTROL SERUM SET
K961550 · KTN System, Test, Infectious... · Immunology
Sep 1996 155d
STABILYPH UNASSAYED LIGAND ASSASY CONTROL, LEVELS 1, 2 AND 3
K963346 · JJY Multi-analyte Controls,... · Chemistry
Sep 1996 14d
QUALITROL CRP CONTROL SET
K961829 · DCK C-reactive Protein,... · Immunology
Aug 1996 98d
QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET
K961912 · JJY Multi-analyte Controls,... · Immunology
Aug 1996 90d
QUALITROL SYPHSERO CONTROL SET
K961998 · GMP Antisera, Control For... · Microbiology
Aug 1996 78d
QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2
K961293 · JJY Multi-analyte Controls,... · Chemistry
May 1996 28d
REFERENCE MATERIAL FOR PHENCYCLIDINE IN HUMAN URINE
K933557 · LAS Drug Specific Control... · Toxicology
Sep 1993 51d
CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL
K905457 · DIF Drug Mixture Control... · Chemistry
Apr 1991 132d
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