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
9721–9744 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 20, 1984
SYSTEMATE GOT 67208
K843333 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 20, 1984
SYSTEMATE GPT 67209
K843334 · CKA
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 20, 1984
RAICHEM CALCIUM REAGENT
K843353 · CIC
Reagents Applications, Inc.
Chemistry · 24d
Cleared Sep 20, 1984
ACID PHOSPHATASE ASSAY KIT
K843380 · CKE
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 23d
Cleared Sep 17, 1984
STRATUS CORTISOL FLUOROMETRIC ENZYME
K843183 · CGR
American Dade
Chemistry · 35d
Cleared Sep 14, 1984
PROLACTIN IRMA
K842478 · CFT
Euro-Diagnostics BV
Chemistry · 81d
Cleared Sep 14, 1984
MACBETH COLOR EIAD 100/100PC
K842770 · JJQ
Macbeth
Chemistry · 60d
Cleared Sep 14, 1984
DYNA-LYTE 2000
K842786 · CEM
Abbott Diagnostics
Chemistry · 115d
Cleared Sep 14, 1984
CORITSOL PREMIX RIA KIT
K842957 · CGR
Biotecx Laboratories, Inc.
Chemistry · 49d
Cleared Sep 14, 1984
DRI-STAT ENZYMATIC BILIRUBIN TEST KIT
K843174 · JFM
Beckman Instruments, Inc.
Chemistry · 32d
Cleared Sep 14, 1984
INORGANIC PHOSPHORUS TEST
K843177 · CEO
Sclavo, Inc.
Chemistry · 32d
Cleared Sep 14, 1984
ANSWER ONE-DAY
K843238 · LCX
Armkel, LLC
Chemistry · 23d
Cleared Sep 14, 1984
TECHNICON RA-1000 SYS IRON FOR SERUM
K843255 · JIY
Technicon Instruments Corp.
Chemistry · 25d
Cleared Sep 14, 1984
SYSTEMATE BUN HEM NO. 67221
K843326 · CDQ
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Sep 14, 1984
SYSTEMATE CHOLESTEROL 67222
K843327 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Sep 14, 1984
SYSTEMATE PHOSPHORUS 67217
K843330 · CEO
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Sep 14, 1984
ALKALINE PHOSPHATASE REAGENT SET
K843332 · CJE
Sterling Biochemical, Inc.
Chemistry · 18d
Cleared Sep 14, 1984
ETHYL ALCOHOL ASSAY KIT
K843378 · DMT
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 17d
Cleared Sep 14, 1984
CORNING HIGH RESOLUTION PROTEIN ELECTRO
K843397 · CEF
Corning Medical & Scientific
Chemistry · 16d
Cleared Sep 13, 1984
AXIOM STABLE II TRIGLYCERIDES TEST
K842443 · CDT
Axiom, Inc.
Chemistry · 84d
Cleared Sep 13, 1984
ROCHE STANDARDS FOR URIC ACID
K843112 · JIT
Roche Diagnostic Systems, Inc.
Chemistry · 37d
Cleared Sep 13, 1984
ID ZONE NORMAL LD ISOENZYME CONTROL
K843266 · JJT
Beckman Instruments, Inc.
Chemistry · 24d
Cleared Sep 13, 1984
SYSTEMATE 2GT - 67207
K843268 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 13, 1984
SYSTEMATE LDH, 67210
K843269 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 24d