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
4369–4392 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 01, 1997
REP SPE VIS-60/40 KIT
K973316 · CEF
Helena Laboratories
Chemistry · 28d
Cleared Sep 29, 1997
MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3
K973451 · JJW
Medical Analysis Systems, Inc.
Chemistry · 18d
Cleared Sep 25, 1997
SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY
K972761 · CFL
Sealite Sciences, Inc.
Chemistry · 63d
Cleared Sep 25, 1997
SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT
K973109 · CIG
Synermed, Inc.
Chemistry · 37d
Cleared Sep 25, 1997
QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFORMANCEMCCLIQUICHEM...
K973469 · JJY
Consolidated Technologies, Inc.
Chemistry · 21d
Cleared Sep 25, 1997
VITROS IMMUNODIAGNOSTIC PRODUCTS RANGE VERIFIERS
K973517 · JJY
Johnson & Johnson Clinical...
Chemistry · 8d
Cleared Sep 24, 1997
CHOLESTEROL RAPID LIQUID REAGENT
K972853 · CHH
Reagents Applications, Inc.
Chemistry · 89d
Cleared Sep 22, 1997
DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K972580 · JMM
Bayer Corp.
Chemistry · 74d
Cleared Sep 22, 1997
SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT
K972743 · CGX
Sigma Diagnostics, Inc.
Chemistry · 61d
Cleared Sep 17, 1997
GLUCOSITE TEST SYSTEM
K971145 · CGA
Gds Technology, LLC
Chemistry · 173d
Cleared Sep 11, 1997
TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY
K972666 · CIN
Hybritech, Inc.
Chemistry · 57d
Cleared Sep 09, 1997
CLINITEK MICROALBUMIN REAGENT STRIPS
K972706 · CJG
Bayer Corp.
Chemistry · 50d
Cleared Sep 09, 1997
AVL OMNI ANALYZER
K972733 · CGA
Avl Scientific Corp.
Chemistry · 50d
Cleared Sep 04, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB...
K973030 · JJY
Johnson & Johnson Clinical...
Chemistry · 21d
Cleared Sep 02, 1997
ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT
K971458 · JIQ
Diagnostic Specialties
Chemistry · 133d
Cleared Sep 02, 1997
FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)
K972720 · CGJ
Monobind
Chemistry · 43d
Cleared Aug 29, 1997
AIA-PACK TSH 3RD-GEN ASSAY
K972586 · JLW
Tosoh Medics, Inc.
Chemistry · 49d
Cleared Aug 29, 1997
PREGNACOL PREGNANCY TEST
K972606 · JHJ
Immunostics Inc.,
Chemistry · 49d
Cleared Aug 29, 1997
QUICKVUE ONE-STEP HCG-URINE
K972742 · JHI
Quidel Corp.
Chemistry · 37d
Cleared Aug 29, 1997
CARDS Q.S. HCG-URINE
K972748 · JHI
Quidel Corp.
Chemistry · 37d
Cleared Aug 29, 1997
CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL
K972976 · JJT
More Diagnostics
Chemistry · 18d
Cleared Aug 28, 1997
AG CHEMISTRY ANALYZER SYSTEM
K972409 · JJG
Landmark Scientific, Inc.
Chemistry · 63d
Cleared Aug 28, 1997
TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL
K972868 · JJY
Bionostics, Inc.
Chemistry · 24d
Cleared Aug 25, 1997
THE YELLOW IRIS URINALYSIS WORKSTATION
K972141 · KQO
Intl. Remote Imaging Systems
Chemistry · 80d