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
8857–8880 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 01, 1986
CREATININE PROCEDURE
K861655 · CGX
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
INORGANIC PHOSPHORUS PROCEDURE
K861661 · CEO
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
AMYLASE PROCEDURE
K861664 · CIJ
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
BLOOD UREA NITROGEN (BUN) PROCEDURE
K861666 · CDQ
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
TRIGLYCERIDE (TRINDER) PROCEDURE
K861670 · CDT
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
BICARBONATE PROCEDURE
K861673 · KHS
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
CHLORIDE PROCEDURE
K861674 · CHJ
Data Medical Associates, Inc.
Chemistry · 62d
Cleared Jul 01, 1986
ELECTROLYTE ANALYZER ACCESSORY FOR HITACHI 704
K861696 · JGS
Boehringer Mannheim Corp.
Chemistry · 57d
Cleared Jul 01, 1986
UNISKAN II
K861897 · JJQ
Flow Laboratories, Inc.
Chemistry · 46d
Cleared Jul 01, 1986
HCG IRMA, CAT. NO. CR-1501
K862007 · JHI
Pacific Biotech, Inc.
Chemistry · 35d
Cleared Jul 01, 1986
SOMAS LIQUID URINE CONTROL
K862179 · JJY
Somas Medical Industries, Inc.
Chemistry · 22d
Cleared Jul 01, 1986
UREA NITROGEN (GLDH) REAGENT SET (UV)
K862210 · CDQ
Sterling Diagnostics, Inc.
Chemistry · 21d
Cleared Jul 01, 1986
ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET
K862256 · CJE
Sterling Diagnostics, Inc.
Chemistry · 18d
Cleared Jul 01, 1986
AMRESCO FLOW PAC TOTAL BILIRUBIN REAGENTS
K862299 · CIG
Amresco, Inc.
Chemistry · 14d
Cleared Jun 30, 1986
ENZYMUN TEST TBG
K862109 · CEE
Boehringer Mannheim Corp.
Chemistry · 27d
Cleared Jun 27, 1986
CRESOLPHTHALEIN COMPLEXONE, CALCIUM
K860664 · CIC
Amresco, Inc.
Chemistry · 123d
Cleared Jun 27, 1986
SUCROSEP HUMAN PROLACTIN (HPR) IRMA
K861271 · CFT
Boots-Celltech Diagnostics, Inc.
Chemistry · 84d
Cleared Jun 27, 1986
ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE
K861361 · CHP
Serono Diagnostics, Inc.
Chemistry · 78d
Cleared Jun 27, 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB)
K861387 · JHS
Eastman Kodak Company
Chemistry · 74d
Cleared Jun 27, 1986
PROGROUP (TM) AUTOMATED LIQUID HANDLING SYSTEM
K861580 · JQW
Cetus Corp.
Chemistry · 60d
Cleared Jun 27, 1986
TRIGLYCERIDES GPO-TRINDER
K861635 · CDT
Catachem, Inc.
Chemistry · 59d
Cleared Jun 27, 1986
TWIN BUN/GLUCOSE
K861775 · CDW
Boehringer Mannheim Corp.
Chemistry · 50d
Cleared Jun 27, 1986
TWIN TRIGLYCERIDES GPO/CHOLESTEROL
K861793 · CDT
Boehringer Mannheim Corp.
Chemistry · 49d
Cleared Jun 27, 1986
WORTHINGTON HDL PRECIPITATING REAGENT SET
K861926 · LBR
Cooper Biomedical, Inc.
Chemistry · 39d