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
5305–5328 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 30, 1995
CIBA CORNING 8-- SERIES CO-OXIMETER
K946206 · CHL
Ciba Corning Diagnostics Corp.
Chemistry · 40d
Cleared Jan 30, 1995
CERTAIN(R) ELITE LEVEL 1, 2 AND 3
K946224 · JJS
Ciba Corning Diagnostics Corp.
Chemistry · 77d
Cleared Jan 27, 1995
ADVANCE(R) PREGNANCY TEST
K945846 · LCX
Advanced Care Products
Chemistry · 58d
Cleared Jan 27, 1995
RAPIDVUE(TM) HCG
K945969 · JHI
Quidel Corp.
Chemistry · 51d
Cleared Jan 24, 1995
CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL
K946145 · JJT
Clinical Controls, Inc.
Chemistry · 39d
Cleared Jan 24, 1995
CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION
K946146 · JJT
Clinical Controls, Inc.
Chemistry · 39d
Cleared Jan 18, 1995
VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE
K945952 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 43d
Cleared Jan 17, 1995
GLUCOCHEK
K940215 · CGA
Clinical Diagnostics, Inc.
Chemistry · 368d
Cleared Jan 17, 1995
MODEL 2721 CLINICAL REFRACTOMETER
K941901 · JRE
Vee Gee Scientific, Inc.
Chemistry · 273d
Cleared Jan 17, 1995
MODEL 2740 CLINICAL REFRACTOMETER
K941903 · JRE
Vee Gee Scientific, Inc.
Chemistry · 273d
Cleared Jan 17, 1995
MODEL 2730 CLINICAL REFRACTOMETER
K941906 · JRE
Vee Gee Scientific, Inc.
Chemistry · 273d
Cleared Jan 17, 1995
AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT
K942661 · JLW
Sealite Sciences, Inc.
Chemistry · 225d
Cleared Jan 17, 1995
EASY LYTE CALCIUM ANALYZER
K943091 · JFP
Medica Corp.
Chemistry · 203d
Cleared Jan 17, 1995
HEMOCUE B-GLUCOSE SYSTEM
K943432 · CGA
Hemocue, Inc.
Chemistry · 186d
Cleared Jan 17, 1995
QUANITITATE GBCC VERIFIER SET
K944454 · JJY
Beckman Instruments, Inc.
Chemistry · 127d
Cleared Jan 17, 1995
QUANTITATE ELECTROLYTE VERIFIER SET (SERUM RANGE)
K944455 · JJY
Beckman Instruments, Inc.
Chemistry · 127d
Cleared Jan 17, 1995
SAS QUANT HCG SERUM
K944785 · JJX
Sa Scientific, Inc.
Chemistry · 111d
Cleared Jan 17, 1995
HCG MIDSTREAM PREGNANCY TEST
K945568 · LCX
Mizuho USA, Inc.
Chemistry · 68d
Cleared Jan 17, 1995
DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SET
K945718 · JJX
Casco Standards
Chemistry · 57d
Cleared Jan 17, 1995
SPECTRUM CO-OXIMETER LINEARITY CONTROL
K945860 · JJS
Phoenix Diagnostics, Inc.
Chemistry · 47d
Cleared Jan 17, 1995
KODAK EKTACCHEM 950IRC ANALYZER
K946090 · JJE
Clinical Diagnostic Systems, Inc.
Chemistry · 35d
Cleared Jan 17, 1995
CEDIA(R) FOLATE (NO BOIL) ASSAY
K946184 · CGN
Microgenics Corp.
Chemistry · 28d
Cleared Jan 09, 1995
PLATO 3300/1300
K943454 · JJQ
Rosys, Inc.
Chemistry · 175d
Cleared Jan 05, 1995
CALCIUM REAGENT
K944258 · CIC
Olympus America, Inc.
Chemistry · 126d