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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,249 results
13129–13152 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 21, 1976
AUTO TOTAL BILIRUBIN REAGENT
K761218 · CIG
Harleco
Chemistry · 14d
Cleared Dec 21, 1976
ELECTROPHORESIS ACCESSORY MO. 3526
K761248 · JJN
Gilford Instrument Laboratories, Inc.
Chemistry · 8d
Cleared Dec 21, 1976
AUTO TOTAL PROTEIN
K761257 · CEK
Harleco
Chemistry · 14d
Cleared Dec 13, 1976
MT II - TEST FOR CONTINUOUS FLOW ANAL
K761165 · JJC
Technicon Instruments Corp.
Chemistry · 12d
Cleared Dec 13, 1976
GLUCOSE OXIDASE REAGENT SYSTEM
K761181 · CGA
Nobel Scientific Industries, Inc.
Chemistry · 11d
Cleared Dec 09, 1976
ANALYZER, PROGRAMMABLE DISCRETE (PDA)
K760642 · JJE
Anatronics Corp.
Chemistry · 86d
Cleared Dec 09, 1976
URIC ACID REAGENT SET
K760989 · CDO
Worthington Biochemical Corp.
Chemistry · 34d
Cleared Dec 09, 1976
S-UREA-N, IN VITRO DIAG FOR BUN
K761152 · CDL
Advanced Biomedical Methods, Inc.
Chemistry · 10d
Cleared Dec 09, 1976
GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE
K761153 · CGA
Advanced Biomedical Methods, Inc.
Chemistry · 10d
Cleared Dec 09, 1976
GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ
K761154 · CGA
Advanced Biomedical Methods, Inc.
Chemistry · 10d
Cleared Dec 06, 1976
RADIO IMMUNO ASSAY KIT/
K760619 · CDD
New England Nuclear
Chemistry · 84d
Cleared Dec 06, 1976
MULTI-CELL ULTRAFILTRATION SYSTEM
K761100 · JQQ
Amicon, Inc.
Chemistry · 13d
Cleared Dec 02, 1976
GAMMACORD II CALCULATOR INTERFACE
K761063 · JQP
Miles Laboratories, Inc.
Chemistry · 14d
Cleared Dec 02, 1976
DIAGNOSTIC METHOD-8-GLUTAMYLTRANSFERASE
K761090 · JQB
Technicon Instruments Corp.
Chemistry · 10d
Cleared Nov 30, 1976
REAGENT SYSTEM (NO. SC 135)
K760711 · JPZ
Sigma Chemical Co.
Chemistry · 66d
Cleared Nov 30, 1976
TEMPERATURE REGULATED FIVE CELL HOLDERS
K760769 · JRI
The Perkin-Elmer Corp.
Chemistry · 57d
Cleared Nov 30, 1976
AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL
K761026 · CIX
Harleco Diagnostics
Chemistry · 18d
Cleared Nov 30, 1976
AUTO-TOTAL BILIRUBIN REAG FOR GILFORD AN
K761027 · CIG
Harleco
Chemistry · 18d
Cleared Nov 30, 1976
AUTO-ALBUMIN REAG FOR ABBOTT ABA-100
K761028 · CIX
Harleco
Chemistry · 18d
Cleared Nov 30, 1976
AUTO-CALCIUM REAG FOR GILFORD 3400E ANAL
K761029 · CJY
Harleco
Chemistry · 18d
Cleared Nov 29, 1976
TRIGLYCERIDES TEST
K760713 · CDT
Boehringer Mannheim Corp.
Chemistry · 66d
Cleared Nov 24, 1976
LANCER AUTOANALYZER MANIFOLD PUMP TUB
K760622 · JJC
Sherwood Medical Industries
Chemistry · 72d
Cleared Nov 24, 1976
ACA PHOSPHORUS ANALYTICAL TEST PACK
K760634 · CEO
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 72d
Cleared Nov 24, 1976
SIGMA PROCED #SC165
K760685 · CJE
Sigma Chemical Co.
Chemistry · 65d