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
9841–9864 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 03, 1984
TRYPTICASE SOY BROTH
K842849 · JSC
Anarobe Systems
Chemistry · 14d
Cleared Aug 02, 1984
SEBUTAPE
K840096
Cuderm Corp.
Chemistry · 205d
Cleared Aug 02, 1984
ULTRA LYTE ANALYZER I 100
K842315 · CEM
Ultra Quest Diagnostics, Inc.
Chemistry · 51d
Cleared Aug 02, 1984
PDA SYSTEM
K842522 · JJG
Abbott Laboratories
Chemistry · 36d
Cleared Jul 26, 1984
STAR HCG MONOCLONAL ANTIBODY IMMUNO
K842598 · JHI
Syncor Intl. Corp.
Chemistry · 35d
Cleared Jul 25, 1984
CLINITEK 10 SEMI-AUTO URINALYSIS SYS
K842238 · KQO
Miles Laboratories, Inc.
Chemistry · 50d
Cleared Jul 25, 1984
CHEMISTRY ANALYZER, GEN. PURPOSE
K842311 · JJQ
Hml Inc/Biotechnology Transfer
Chemistry · 43d
Cleared Jul 25, 1984
AXIOM STABLE II CHOLESTEROL TEST
K842441 · CHH
Axiom, Inc.
Chemistry · 34d
Cleared Jul 20, 1984
LACTATE DEHYDROGENASE ASSAY KIT
K842507 · CFJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 24d
Cleared Jul 20, 1984
CREATINE KINASE ASSAY KIT NAC
K842508 · CGS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 24d
Cleared Jul 20, 1984
CALCIUM ASSAY KIT
K842509 · CIC
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 24d
Cleared Jul 20, 1984
GLUCOSE ASSAY KIT-HEXOKINASE
K842510 · CFR
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 24d
Cleared Jul 19, 1984
GLUCOSE-TRINDER-ADDAY KIT
K842506 · CGA
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 23d
Cleared Jul 18, 1984
ALANINE AMINOTRANSFERASE ASSAY KIT
K842241 · CKA
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 43d
Cleared Jul 18, 1984
UREA ASSAY KIT
K842242 · CDQ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 43d
Cleared Jul 18, 1984
ALKALINE PHOSPHATASE ASSAY KIT
K842243 · CJE
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 43d
Cleared Jul 18, 1984
LACTATE DENYDRO GENASE ASSAY KIT
K842244 · CFJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 43d
Cleared Jul 18, 1984
ASPARTATE AMINOTRANSFERASE ASSAY KIT
K842245 · CIT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 43d
Cleared Jul 18, 1984
URIC ACID ASSAY KIT
K842246 · KNK
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 43d
Cleared Jul 17, 1984
ORTHO BRAND HOME PREGNANCY TEST
K842265 · LCX
Advanced Care Products
Chemistry · 40d
Cleared Jul 16, 1984
ATAGO URINE SPECIFIC GRAVITY & SERUM
K842168 · JRE
Kyoto Diagnostics, Inc.
Chemistry · 46d
Cleared Jul 12, 1984
SLIDE PREGNANCY TEST
K842110 · JHJ
Immunostics Co., Inc.
Chemistry · 44d
Cleared Jul 12, 1984
WAKO GLUCOSE C
K842221 · CGA
Wako Pure Chemical Industries, Ltd.
Chemistry · 37d
Cleared Jul 11, 1984
BETA STICK, PREGNANCY TEST
K841415 · LCX
Quidel Corp.
Chemistry · 97d