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
8377–8400 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 28, 1987
CESIUM DILUENT 1.5 MMOL CS/L #60087
K871186 · JIS
In Vitro Diagnostics, Inc.
Chemistry · 65d
Cleared May 28, 1987
LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084
K871187 · JIS
In Vitro Diagnostics, Inc.
Chemistry · 65d
Cleared May 28, 1987
LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086
K871188 · JIS
In Vitro Diagnostics, Inc.
Chemistry · 65d
Cleared May 28, 1987
COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS
K871484 · LGS
Roche Diagnostic Systems, Inc.
Chemistry · 43d
Cleared May 27, 1987
CREATININE STANDARD SOLUTION CALIBRATOR
K871756 · JIT
Wako Chemicals USA, Inc.
Chemistry · 22d
Cleared May 26, 1987
GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA
K864282 · CGA
Medical Device Consultants, Inc.
Chemistry · 208d
Cleared May 26, 1987
MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT
K870904 · JLW
Micromedic Systems
Chemistry · 82d
Cleared May 26, 1987
CIBA CORNING MAGIC(R) LITE CKMB IMMUNOASSAY
K870987 · JHX
Ciba Corning Diagnostics Corp.
Chemistry · 76d
Cleared May 26, 1987
TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS
K870998 · JJC
Technicon Instruments Corp.
Chemistry · 76d
Cleared May 26, 1987
MICROMEDIC NEONATAL T4 KIT
K871008 · CDX
Micromedic Systems
Chemistry · 74d
Cleared May 26, 1987
ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8
K871150 · JIT
Beckman Instruments, Inc.
Chemistry · 64d
Cleared May 26, 1987
SYVA Q-SPEC PHOTOMETER
K871307 · JJQ
Syva Co.
Chemistry · 55d
Cleared May 26, 1987
AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT
K871505 · JLW
Micromedic Systems
Chemistry · 39d
Cleared May 26, 1987
GLUCOSE STANDARD SOLUTION CALIBRATOR
K871758 · JIT
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
MAGNESIUM STANDARD SOLUTION CALIBRATOR
K871762 · JIT
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
NEFA STANDARD SOLUTION CALIBRATOR
K871763 · JIT
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
INORGANIC PHOSPHOROUS STANDARD SOLUTION CALIBRATOR
K871764 · JIT
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
PHOSPHOLIPIDS STANDARD SOLUTION CALIBRATOR
K871765 · JIT
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
TRIGLYCERIDE STANDARD SOLUTION CALIBRATOR
K871766 · JIT
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
UREA N STANDARD SOLUTION CALIBRATOR
K871767 · JIT
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
URIC ACID STANDARD SOLUTION CALIBRATOR
K871768 · JIT
Wako Chemicals USA, Inc.
Chemistry · 21d
Cleared May 26, 1987
ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT)
K871782 · CKA
Biochemical Trade, Inc.
Chemistry · 20d
Cleared May 26, 1987
SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA)
K871811 · CIC
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared May 26, 1987
BIOMEK 1000C AUTOMATED LABORATORY WORK STATION
K871838 · JJG
Beckman Instruments, Inc.
Chemistry · 14d