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
7945–7968 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 05, 1988
SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER
K880949 · CJY
Advanced Biomedical Methods, Inc.
Chemistry · 29d
Cleared Apr 05, 1988
STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01
K881254 · JQC
Norfolk Scientific, Inc.
Chemistry · 13d
Cleared Mar 24, 1988
CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA)
K874875 · CEC
Boots-Celltech Diagnostics, Inc.
Chemistry · 118d
Cleared Mar 24, 1988
WESBLOT PROCESSOR
K874887 · KPA
American Bionetics, Inc.
Chemistry · 114d
Cleared Mar 24, 1988
ABBOTT IMX HCG
K880070 · JHI
Abbott Laboratories
Chemistry · 72d
Cleared Mar 24, 1988
THEOPHYLLINE TEST KIT REF. #A874799
K880291 · LCA
Photec Diagnostics, Inc.
Chemistry · 59d
Cleared Mar 24, 1988
LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY
K880296 · CFT
London Diagnostics, Inc.
Chemistry · 59d
Cleared Mar 24, 1988
WAKO(TM) AUTOKIT TOTAL PROTEIN
K880312 · CEK
Wako Chemicals USA, Inc.
Chemistry · 59d
Cleared Mar 24, 1988
WAKO(TM) AUTOKIT ALBUMIN
K880313 · CIX
Wako Chemicals USA, Inc.
Chemistry · 59d
Cleared Mar 24, 1988
STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR
K880467 · JIY
Stanbio Laboratory
Chemistry · 50d
Cleared Mar 24, 1988
TOTAL IRON BINDING CAPACITY (TIBC)
K880546 · JMO
Boehringer Mannheim Corp.
Chemistry · 44d
Cleared Mar 24, 1988
UNIMETER CALIBRATION KIT
K880610 · JIW
Boehringer Mannheim Corp.
Chemistry · 41d
Cleared Mar 24, 1988
EMIT THYROXINE ASSAY
K880620 · KLI
Syva Co.
Chemistry · 37d
Cleared Mar 24, 1988
PARAMAX AMMONIA REAGENT
K880651 · JIF
Baxter Healthcare Corp
Chemistry · 36d
Cleared Mar 24, 1988
INORGANIC PHOSPHORUS REAGENT SET
K880676 · CEO
Tech-Neal Scientific, Inc.
Chemistry · 34d
Cleared Mar 24, 1988
TOTAL PROTEIN REAGENT SET
K880677 · CEK
Tech-Neal Scientific, Inc.
Chemistry · 34d
Cleared Mar 24, 1988
CORTISOL ENHANCED LUMINESCENCE ASSAY KIT
K880687 · CGR
Amersham Corp.
Chemistry · 31d
Cleared Mar 24, 1988
QUANTIMETRIX SERUM ENZYME CONTROL
K880701 · JJT
Quantimetrix Corp.
Chemistry · 31d
Cleared Mar 24, 1988
PROTEIN BASE ISE CONTROL
K880710 · JJR
Bionostics, Inc.
Chemistry · 31d
Cleared Mar 24, 1988
WAKO AUTOKIT URIC ACID
K880731 · KNK
Wako Chemicals USA, Inc.
Chemistry · 29d
Cleared Mar 23, 1988
CREATININE
K880629 · CGX
Tech-Co, Inc.
Chemistry · 36d
Cleared Mar 16, 1988
LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1)
K880496 · JJW
Bio-Rad
Chemistry · 41d
Cleared Mar 16, 1988
ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM)
K880609 · KHS
Technicon Instruments Corp.
Chemistry · 33d
Cleared Mar 16, 1988
LACTATE DEHYDROGENASE (LDH-L)
K880630 · CFH
Tech-Co, Inc.
Chemistry · 29d