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
3385–3408 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Aug 24, 2001
RANDOX HUMAN ASSSAYED DRUG CONTROL
K012319 · DIF
Randox Laboratories, Ltd.
Chemistry · 32d
Cleared Aug 24, 2001
QUIK-CHECK OVULATION PREDICTOR
K012252 · CEP
ACON Laboratories, Inc.
Chemistry · 37d
Cleared Aug 21, 2001
JAS URIC ACID LIQUID REAGENT
K012038 · KNK
Jas Diagnostics, Inc.
Chemistry · 53d
Cleared Aug 20, 2001
MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER
K012478 · CHL
I-Stat Corp.
Chemistry · 18d
Cleared Aug 20, 2001
IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)
K012311 · LCD
Diagnostic Products Corp.
Chemistry · 28d
Cleared Aug 20, 2001
MCC URICHECK ASSAYED LIQUID URINE MULTICONSTITUENT CONTROL
K012243 · JJY
Hematronix, Inc.
Chemistry · 34d
Cleared Aug 20, 2001
VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005
K012122 · JJX
Maine Standards Co.
Chemistry · 45d
Cleared Aug 20, 2001
VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004
K012120 · JJY
Maine Standards Co.
Chemistry · 45d
Cleared Aug 20, 2001
VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003
K012119 · JJY
Maine Standards Co.
Chemistry · 45d
Cleared Aug 20, 2001
VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002
K012118 · JJY
Maine Standards Co.
Chemistry · 45d
Cleared Aug 20, 2001
VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001
K012117 · JJY
Maine Standards Co.
Chemistry · 45d
Cleared Aug 20, 2001
STAT PROFILE PHOX PLUS L ANALYZER
K012058 · CHL
Nova Biomedical Corp.
Chemistry · 49d
Cleared Aug 14, 2001
SURE CHECK PREGNANCY TEST
K011551 · LCX
Chembio Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Aug 14, 2001
HCG STAT PAK ULTRA-FAST
K011550 · JHI
Chembio Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Aug 10, 2001
GENZYME DIRECT-AMYLASE TEST REAGENT
K011843 · JFJ
Genzyme Corp.
Chemistry · 59d
Cleared Aug 10, 2001
QUICKTEK BLOOD GLUCOSE SYSTEM, QUICKTEK BLOOD GLUCOSE METER, QUICKTEK BLOOD...
K010039 · NBW
Chronimed, Inc.
Chemistry · 217d
Cleared Aug 09, 2001
MODIFICATION TO ACCU-CHEK INFORM METER
K012210 · NBW
Roche Diagnostics Corp.
Chemistry · 24d
Cleared Aug 08, 2001
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
K012286 · LBS
Roche Diagnostics Corp.
Chemistry · 19d
Cleared Aug 07, 2001
MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
K012287 · MRR
Roche Diagnostics Corp.
Chemistry · 18d
Cleared Aug 07, 2001
QUIK-CHECK HOME PREGNANCY TEST
K012215 · LCX
ACON Laboratories, Inc.
Chemistry · 22d
Cleared Aug 07, 2001
PRAXSYS RELIA TSH TEST
K011527 · JLW
Praxsys Biosystems, Inc.
Chemistry · 82d
Cleared Aug 03, 2001
EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229
K012257 · DKZ
Syva Co.
Chemistry · 16d
Cleared Aug 01, 2001
AUTOMATED WORKCELL CONTROL SOFTWARE
K010500 · JJE
Lab-Interlink, Inc.
Chemistry · 161d
Cleared Jul 31, 2001
GLUCOSE (HEXOKINASE)
K011900 · CFR
Jas Diagnostics, Inc.
Chemistry · 43d