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
4585–4608 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 11, 1997
ONE-STEP URINE/SERUM COMNO PREGNANCY DIPSTICK TEST
K964462 · JHI
Teco Diagnostics
Chemistry · 96d
Cleared Feb 11, 1997
ONE-STEP DIPSTICK PREGNANCY TEST
K964536 · JHI
Teco Diagnostics
Chemistry · 91d
Cleared Feb 11, 1997
CANTROL SERUM IRON AND TOTAL IRON BINDING CAPACITY TEST SYSTEM
K970248 · JQE
Canyon Diagnostics, Inc.
Chemistry · 20d
Cleared Feb 10, 1997
GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS
K964004 · CFR
Bayer Corp.
Chemistry · 126d
Cleared Feb 10, 1997
CARDIAC T TROPONIN T RAPID ASSAY
K964372 · MMI
Boehringer Mannheim Corp.
Chemistry · 101d
Cleared Feb 10, 1997
GLUCOMETER ELITE BLOOD GLUCOSE METER
K964630 · CGA
Bayer Corp.
Chemistry · 83d
Cleared Feb 10, 1997
TROPONIN-I TEST SYSTEM
K964862 · MMI
Dade Intl., Inc.
Chemistry · 68d
Cleared Feb 10, 1997
VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET
K965202 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 46d
Cleared Feb 10, 1997
ELECSYS CALCHECK PROLACTIN
K970147 · JJY
Boehringer Mannheim Corp.
Chemistry · 26d
Cleared Feb 10, 1997
ELECSYS CALCHECK ESTRADIOL
K970148 · JJX
Boehringer Mannheim Corp.
Chemistry · 26d
Cleared Feb 07, 1997
FEMEXAM TESTCARD
K962718 · CEN
Litmus Concepts, Inc.
Chemistry · 210d
Cleared Feb 06, 1997
STABLELIN ENZYME LINEARITY TEST SET C (ITEM NO. 003)
K965169 · JJT
Specialized Assays, Inc.
Chemistry · 44d
Cleared Feb 06, 1997
HCG CONTROLS
K970176 · JJX
International Newtech Development, Inc.
Chemistry · 20d
Cleared Feb 04, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS
K963673 · KLT
Beckman Instruments, Inc.
Chemistry · 144d
Cleared Feb 04, 1997
VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH...
K964720 · CGJ
Johnson & Johnson Clinical...
Chemistry · 71d
Cleared Feb 04, 1997
ALKALINE PHOSPHATASE
K964914 · CJE
Derma Media Lab., Inc.
Chemistry · 57d
Cleared Feb 04, 1997
STABLELIN ENZYME LINERARITY TEST SET A (ITEM NO. 001)
K965166 · JJT
Specialized Assays, Inc.
Chemistry · 42d
Cleared Feb 04, 1997
STABLELIN ENZYME LINEARITY TEST SET B (ITEM NO. 002)
K965168 · JJT
Specialized Assays, Inc.
Chemistry · 42d
Cleared Feb 04, 1997
PERFECTA PREGNANCY TEST
K965184 · LCX
Wyntek Diagnostics, Inc.
Chemistry · 42d
Cleared Feb 04, 1997
OSOM CLASSIC HCG-URINE TEST (115)
K965227 · JHI
Wyntek Diagnostics, Inc.
Chemistry · 36d
Cleared Jan 30, 1997
VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3...
K970016 · CDP
Johnson & Johnson Clinical...
Chemistry · 28d
Cleared Jan 30, 1997
ELECSYS CALCHECK TESTOSTERONE
K970146 · JJX
Boehringer Mannheim Corp.
Chemistry · 15d
Cleared Jan 27, 1997
VITROS IMMUNODDIAGNOSTICS PRODUCTS RE CONTROLS (GEM.5015)
K965048 · JJY
Johnson & Johnson Clinical...
Chemistry · 40d
Cleared Jan 24, 1997
MICRO H2
K963376 · NRH
Micro Direct, Inc.
Chemistry · 150d