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
4393–4416 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 20, 1997
AVL 9181 ELECTROLYTE ANALYZER
K972673 · JFP
Avl Scientific Corp.
Chemistry · 35d
Cleared Aug 19, 1997
IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)
K972861 · JJS
Instrumentation Laboratory CO
Chemistry · 15d
Cleared Aug 15, 1997
IL TEST IRON
K972363 · JIY
Instrumentation Laboratory CO
Chemistry · 51d
Cleared Aug 15, 1997
QUANTIFY(901)
K972710 · JJW
Hematronix, Inc.
Chemistry · 25d
Cleared Aug 15, 1997
DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
K972782 · JHX
Dade Intl., Inc.
Chemistry · 21d
Cleared Aug 12, 1997
ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
K972250 · JFJ
Roche Diagnostic Systems, Inc.
Chemistry · 57d
Cleared Aug 08, 1997
PRECISION QID BLOOD GLUCOSE TEST STRIP, PRECISION G BLOOD GLUCOSE TEST STRIP
K971812 · CGA
Medisense, Inc.
Chemistry · 84d
Cleared Aug 08, 1997
DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA
K972337 · JIR
Diagnostic Chemicals , Ltd.
Chemistry · 46d
Cleared Aug 07, 1997
SYNERMED TOTAL BILIRUBIN REAGENT KIT
K972716 · CIG
Synermed, Inc.
Chemistry · 17d
Cleared Aug 06, 1997
ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P
K972721 · JJX
Roche Diagnostic Systems, Inc.
Chemistry · 16d
Cleared Aug 04, 1997
PLASMA CATECHOLAMINE KIT
K972167 · CHQ
Bioanalytical Systems, Inc.
Chemistry · 56d
Cleared Aug 01, 1997
GLUCOSE REAGENT
K970664 · CFR
Derma Media Lab., Inc.
Chemistry · 161d
Cleared Aug 01, 1997
UREA
K971309 · CDQ
Derma Media Lab., Inc.
Chemistry · 115d
Cleared Aug 01, 1997
QUICKSTICK ONE STEP HCG PREGNANCY TEST
K972682 · LCX
Phamatech
Chemistry · 15d
Cleared Jul 30, 1997
CODA AUTOMATED EIA ANALYZER
K972024 · JJI
Bio-Rad
Chemistry · 58d
Cleared Jul 28, 1997
CARDIAC STATUS CONTROLS/TROPONIN I
K972687 · JJX
Spectral Diagnostics, Inc.
Chemistry · 11d
Cleared Jul 25, 1997
IMMULITE FREE T4 (2-STEP)
K971792 · CEC
Diagnostic Products Corp.
Chemistry · 71d
Cleared Jul 25, 1997
CARDIAC STATUS CONTROLS
K972408 · JJT
Spectral Diagnostics, Inc.
Chemistry · 29d
Cleared Jul 24, 1997
COLORMATE III
K964590 · MQM
Chromatics Color Sciences Intl., Inc.
Chemistry · 251d
Cleared Jul 24, 1997
PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST
K971825 · JFJ
Randox Laboratories, Ltd.
Chemistry · 69d
Cleared Jul 24, 1997
CHOLESTECH BUN/CREATININE TEST SYSTEM
K972012 · CDN
Cholestech Corp.
Chemistry · 55d
Cleared Jul 23, 1997
TARGET CARDIAC TROPONIN I TEST
K972094 · MMI
Texas Immunology, Inc.
Chemistry · 49d
Cleared Jul 23, 1997
AMMONIA/IRON STANDARD KIT
K972333 · JIX
Verichem Laboratories, Inc.
Chemistry · 30d
Cleared Jul 22, 1997
LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
K971754 · CFR
Pointe Scientific, Inc.,
Chemistry · 71d