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
3481–3504 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 13, 2001
ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349
K010428 · JJX
Beckman Coulter, Inc.
Chemistry · 28d
Cleared Mar 13, 2001
N LATEX CYSTATIN C
K003503 · NDY
Dade Behring, Inc.
Chemistry · 120d
Cleared Mar 07, 2001
ACCU-CHEK COMFORT CURVE TEST STRIP
K010362 · LFR
Roche Diagnostics Corp.
Chemistry · 29d
Cleared Mar 01, 2001
ELECSYS TESTOSTERONE CALSET II
K003411 · JIT
Roche Diagnostics Corp.
Chemistry · 119d
Cleared Feb 28, 2001
CARDIOIMMUNE TL CARDIAC MARKER CONTROL LEVELS 1, 2, 3, AND MULTI-PACK
K010111 · JJY
Medical Analysis Systems, Inc.
Chemistry · 47d
Cleared Feb 21, 2001
PHOSPHORUS REAGENT
K003912 · CEO
Jas Diagnostics, Inc.
Chemistry · 64d
Cleared Feb 21, 2001
EZ-HCG URINE(PREGNANCY TEST)
K003856 · JHI
Biomerica, Inc.
Chemistry · 70d
Cleared Feb 20, 2001
DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137
K010208 · JIT
Dade Behring, Inc.
Chemistry · 28d
Cleared Feb 20, 2001
TOTAL BILIRUBIN REAGENT
K003892 · CIG
Intersect Systems, Inc.
Chemistry · 64d
Cleared Feb 14, 2001
ELECSYS HCG+B CALCHECK
K010237 · JJX
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Feb 14, 2001
LIQUISPX HDL/LDL LIQUID CHOLESTEROL CALIBRATOR
K010030 · JIX
Synergent Biochem Inc.-Clinical...
Chemistry · 42d
Cleared Feb 14, 2001
IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS)
K004002 · JHX
Diagnostic Products Corp.
Chemistry · 50d
Cleared Feb 14, 2001
DELFIA NEONATAL IRT KIT, MODEL A005-110
K003664 · CGZ
Wallac OY
Chemistry · 78d
Cleared Feb 12, 2001
TOTAL BILIRUBIN
K003829 · CIG
Jas Diagnostics, Inc.
Chemistry · 63d
Cleared Feb 12, 2001
AUTODELFIA NEONATAL IRT KIT, MODEL B005-112
K003668 · CGZ
Wallac OY
Chemistry · 76d
Cleared Feb 05, 2001
ADVIA CENTAUR AND ACS: 180 FOLATE IMMUNOASSAY
K010050 · CGN
Bayer Diagnostics Corp.
Chemistry · 31d
Cleared Feb 05, 2001
RANDOX TRANSFERRIN
K002585 · DDG
Randox Laboratories, Ltd.
Chemistry · 168d
Cleared Feb 02, 2001
EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER
K002407 · JGS
Medica Corp.
Chemistry · 179d
Cleared Feb 01, 2001
PERSONAL GLUCOSE CONTROL CHARTING SYSTEM
K002688 · CGA
Lxn Corp.
Chemistry · 156d
Cleared Jan 29, 2001
DIRECT BILIRUBIN
K003693 · CIG
Jas Diagnostics, Inc.
Chemistry · 60d
Cleared Jan 26, 2001
ELECSYS FSH CALSET II
K003409 · JIT
Roche Diagnostics Corp.
Chemistry · 85d
Cleared Jan 25, 2001
ELECSYS HCG STAT CLASET II
K003941 · JIS
Roche Diagnostics Corp.
Chemistry · 35d
Cleared Jan 25, 2001
STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG,...
K003696 · DHA
Dade Behring, Inc.
Chemistry · 56d
Cleared Jan 22, 2001
WAKO CRP-UL, CRP-UL CALIBRATOR SET
K003342 · DCN
Wako Chemicals USA, Inc.
Chemistry · 89d