Medical Device Manufacturer · US , Mchenry , IL

Emd Chemicals, Inc.

62 submissions · 62 cleared · Since 1982
62
Total
62
Cleared
0
Denied

Emd Chemicals, Inc. — FDA 510(k) Submissions

Emd Chemicals, Inc. has submitted 62 FDA 510(k) premarket notifications since 1982, of which 62 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzymatic Esterase--oxidase, Cholesterol, Calibrator, Primary, Urease And Glutamic Dehydrogenase, Urea Nitrogen, Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes, Calibrator, Secondary . Use the specialty filter in the sidebar to narrow results.

62 devices
1–25 of 62
DUOPATH VEROTOXINS GLISA TEST
K031367 · GNA Antisera, All Types,... · Microbiology
Jan 2004 268d
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
K990516 · DNN Calibrators, Ethyl Alcohol · Toxicology
Mar 1999 41d
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
K981926 · DLJ Calibrators, Drug Specific · Toxicology
Jul 1998 50d
ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
K973054 · DNN Calibrators, Ethyl Alcohol · Toxicology
Oct 1997 47d
AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)
K951494 · CIJ Saccharogenic, Amylase · Chemistry
Dec 1995 255d
GLUCOSE TEST ITEM NUMBER 97375/94
K951750 · LFR Glucose Dehydrogenase,... · Chemistry
Sep 1995 142d
TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2
K950234 · CEK Biuret (colorimetric),... · Chemistry
Jun 1995 152d
TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2
K950128 · CEK Biuret (colorimetric),... · Chemistry
May 1995 123d
PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416
K945322 · CEO Phosphomolybdate... · Chemistry
Dec 1994 36d
PHOSPHORUS TEST (PHOS)
K945368 · CEO Phosphomolybdate... · Chemistry
Dec 1994 43d
UNIPAK 100 ANALYZER, 65156 & CHEMISTR
K840883 · JJE Analyzer, Chemistry... · Chemistry
May 1984 79d
UNITIZED HEMATOLOGY SET 65132/93
K840477 · GIF Diluent, Blood Cell · Hematology
Mar 1984 31d
ELTRACHEM DIATRAC GLYCOSYLATED HEMOGLOB
K834294 · LCP Assay, Glycosylated... · Hematology
Jan 1984 47d
EPOS CHEMISTRY ANALYZER 5060 & 6410
K833448 · JJE Analyzer, Chemistry... · Chemistry
Dec 1983 78d
SERUM IRON & TIBC#65084 & 65085
K833017 · JIY Photometric Method, Iron... · Chemistry
Nov 1983 58d
TRUST RPR CARD TEST #65144
K832479 · GMQ Antigens, Nontreponemal, All · Hematology
Sep 1983 48d
TRUST RPR TITRATION CARD TEST #65145
K832480 · GMQ Antigens, Nontreponemal, All · Hematology
Sep 1983 48d
EXTRELUT QE EXTRACTION COLUMNS
K831027 · KEA Resins, Ion-exchange · Toxicology
May 1983 47d
IMMUNOHEMATOLOGICAL SALINE #97139
K831200 · JCE Solution, Isotonic · Chemistry
May 1983 28d
RHEUMATOID FACTOR-RAPID CARD TEST #65114
K830832 · DHR System, Test, Rheumatoid... · Immunology
Apr 1983 33d
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDA
K830239 · CHH Enzymatic... · Chemistry
Apr 1983 70d
ULTRA CHEM BUN-UV #65080-65081
K830241 · CDQ Urease And Glutamic... · Chemistry
Apr 1983 70d
ULTRA ZYME PLUS GAMMA GT #65055 & 56
K830308 · JQB Kinetic Method,... · Chemistry
Feb 1983 28d
ULTRA CHEM ENZYMATIC CHOLESTEROL OXIDASE
K830309 · CHH Enzymatic... · Chemistry
Feb 1983 28d
ULTRA CHEM CRESOLCAVERSACHEM #65082
K830238 · CIC Cresolphthalein... · Chemistry
Feb 1983 24d
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