FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
9793–9816 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 24, 1984
FIXED VOL. DISPENSERS, ADJUST VOL-HUNPIP
K843073 · JQW
Greene International Corp.
Chemistry · 18d
Cleared Aug 23, 1984
BETA SCAN DRYSTIX
K841369 · CGA
Orange Medical Instruments, Inc.
Chemistry · 142d
Cleared Aug 23, 1984
TANDEM FAST VISUAL HCG ASSAY KIT -
K842633 · JHI
Hybritech, Inc.
Chemistry · 45d
Cleared Aug 22, 1984
BETA-HCG HEMAGGLUTINATION TEST
K842181 · JHJ
Sero-Immuno Diagnostics, Inc.
Chemistry · 82d
Cleared Aug 22, 1984
QCA TRIGLYCERIDES
K842891 · CDT
Bd Becton Dickinson Vacutainer...
Chemistry · 30d
Cleared Aug 17, 1984
ACTH STANDARD MATRIX
K842099 · JIT
Diagnostic Systems Laboratories, Inc.
Chemistry · 84d
Cleared Aug 17, 1984
CHOLESTEROL ASSSAY KIT
K842160 · CHH
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 79d
Cleared Aug 17, 1984
ACA CONJUGATED BILIRUBIN ANALYTICAL
K842385 · CIG
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 60d
Cleared Aug 17, 1984
FSH RIA
K842444 · CGJ
Syncor Intl. Corp.
Chemistry · 57d
Cleared Aug 17, 1984
SANDARE ACID PHOSPHATASE PROCEDURE
K842516 · CJR
Sandare Chemical Co., Inc.
Chemistry · 38d
Cleared Aug 17, 1984
BLOOD GAS FLUSH SOL. & FLUSH AGENT 1302
K842519 · CHL
Rna Medical Corp.
Chemistry · 38d
Cleared Aug 17, 1984
COAT-A-COUNT DHEA-SO4 RIA KIT
K842552 · JKC
Diagnostic Products Corp.
Chemistry · 46d
Cleared Aug 17, 1984
COAT-A-COUNT DHEA RIA KIT
K842606 · JKC
Diagnostic Products Corp.
Chemistry · 43d
Cleared Aug 17, 1984
OSMOTIC PRESSURE AUTO & STAT OM-6010
K842750 · JJM
Kyoto Diagnostics, Inc.
Chemistry · 35d
Cleared Aug 17, 1984
TECHNICON RA-1000 SYS, DIRECT BILIRUBIN
K842809 · CIG
Technicon Instruments Corp.
Chemistry · 30d
Cleared Aug 16, 1984
CREATININE ASSAY KIT-KINETIC OR ENDPOINT
K842159 · CGX
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 78d
Cleared Aug 16, 1984
CORTI-COTE CORTISOL SOLID PHASE RADIO
K842365 · CGR
Bd Becton Dickinson Vacutainer...
Chemistry · 62d
Cleared Aug 16, 1984
BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE
K842393 · CGA
Boehringer Mannheim Corp.
Chemistry · 59d
Cleared Aug 16, 1984
AXIOM STABLE II URIC ACID TEST
K842442 · KNK
Axiom, Inc.
Chemistry · 56d
Cleared Aug 16, 1984
HICHEM ION 2/4 SERUM RANGE CALIBRATOR
K842449 · JIS
Hi Chem, Inc.
Chemistry · 55d
Cleared Aug 16, 1984
HICHEM ION 2/4 URINE RANGE CALIBRATOR
K842450 · JIS
Hi Chem, Inc.
Chemistry · 55d
Cleared Aug 16, 1984
AMER. BIO-SCIENCE LAB CORTISOL REAGENT
K842455 · CGR
American Bio-Science Laboratories
Chemistry · 55d
Cleared Aug 16, 1984
DATA MGMT. SYSTEM
K842500 · JJE
Gilford
Chemistry · 51d
Cleared Aug 15, 1984
CLINITEK 200 SEMI-AUTOMATED URINALYSIS
K842237 · KQO
Miles Laboratories, Inc.
Chemistry · 71d