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
3169–3192 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 25, 2002
ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2
K021316 · LBS
Genzyme Corp.
Chemistry · 91d
Cleared Jul 23, 2002
ACCU-CHEK COMPACT SYSTEM
K022171 · NBW
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Jul 22, 2002
IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)
K022118 · JHX
Diagnostic Products Corp.
Chemistry · 21d
Cleared Jul 22, 2002
CALIBRATING MATERIAL, BUFFERS, STANDARD
K022027 · JIT
Mission Diagnostics
Chemistry · 31d
Cleared Jul 19, 2002
MODIFICATION TO RAICHEM CALCIUM REAGENT
K022049 · CJY
Hemagen Diagnostics, Inc.
Chemistry · 25d
Cleared Jul 19, 2002
JAS HDL CHOLESTEROL (AUTOMATED) REAGENT
K021671 · LBS
Jas Diagnostics, Inc.
Chemistry · 59d
Cleared Jul 19, 2002
CHEMWELL, ALSO KNOWN AS PROJECT 2900
K013420 · JLW
Awareness Technology, Inc.
Chemistry · 277d
Cleared Jul 18, 2002
VIDAS TESTOSTERONE (TES), MODEL 30 418
K021326 · CDZ
bioMerieux, Inc.
Chemistry · 83d
Cleared Jul 17, 2002
ALBUMIN REAGENT
K021636 · CJW
Intersect Systems, Inc.
Chemistry · 61d
Cleared Jul 17, 2002
ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE
K021526 · LFG
ACON Laboratories, Inc.
Chemistry · 68d
Cleared Jul 16, 2002
EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER
K021515 · CHL
Medica Corp.
Chemistry · 67d
Cleared Jul 15, 2002
LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD
K020968 · JHI
Pan Probe Biotech, Inc.
Chemistry · 111d
Cleared Jul 13, 2002
AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K021151 · JIF
Bayer Diagnostics Corp.
Chemistry · 94d
Cleared Jul 12, 2002
HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134
K022053 · JHO
Sebia
Chemistry · 18d
Cleared Jul 12, 2002
GLUCOSE CONTROL SOLUTION FOR BD LATITUDE
K021697 · JJX
Bionostics, Inc.
Chemistry · 51d
Cleared Jul 12, 2002
RNA GL4 GLUCOSE CALIBRATION VERIFICATION CONTROL, MODEL RNA CVC GL4
K021624 · JJX
Bionostics, Inc.
Chemistry · 57d
Cleared Jul 12, 2002
ATAC PAK BUN REAGENT
K021385 · CDQ
Elan Diagnostics
Chemistry · 71d
Cleared Jul 05, 2002
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
K021428 · JFY
Bayer Corp.
Chemistry · 63d
Cleared Jul 03, 2002
MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM
K021827 · NBW
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Jul 03, 2002
WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC...
K021332 · CGS
Wiener Laboratories Saic
Chemistry · 68d
Cleared Jul 03, 2002
POLY-CHEM GLUCOSE
K020852 · CFR
Polymedco, Inc.
Chemistry · 110d
Cleared Jul 03, 2002
CARESIDE LDH
K020484 · CFH
Careside, Inc.
Chemistry · 140d
Cleared Jul 02, 2002
SAMPLOK LUER KIT
K021941 · JKA
Itl Corporation Pty, Ltd.
Chemistry · 19d
Cleared Jul 01, 2002
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP) TEST
K021317 · NBC
Biosite Incorporated
Chemistry · 67d