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
5905–5928 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Mar 23, 1993
VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD
K925916 · LQL
Biomerieux Vitek, Inc.
Chemistry · 120d
Cleared Mar 19, 1993
CIBA CORNING ACS HCG IMMUNOASSAY
K925277 · JHI
Ciba Corning Diagnostics Corp.
Chemistry · 150d
Cleared Mar 18, 1993
DC-UIBC-CAL
K925877 · JIS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 119d
Cleared Mar 18, 1993
PRECISE(TM) HCG(URINE/SERUM) AND PRCISE(TM) PREG
K926356 · JHI
Becton Dickinson Advanced Diagnostics
Chemistry · 87d
Cleared Mar 18, 1993
AUTOBEAD(TM) T4 ENZYME IMMUNOASSAY TEST KIT
K926563 · CDX
Bio-Chem Laboratory Systems, Inc.
Chemistry · 77d
Cleared Mar 18, 1993
PRECISE PREGNANCY
K930640 · LCX
Bd Becton Dickinson Vacutainer...
Chemistry · 49d
Cleared Mar 12, 1993
NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY
K923532 · JLW
Solarcare Technologies Corp,Inc.
Chemistry · 239d
Cleared Mar 09, 1993
CALIBRATION VERIFICATION KIT OR CVK
K924802 · JJY
Radiometer America, Inc.
Chemistry · 166d
Cleared Mar 05, 1993
IMMULITE PROLACTIN
K925846 · CFT
Diagnostic Products Corp.
Chemistry · 107d
Cleared Mar 04, 1993
AIA-PACK AFP CALIBRATION VERIFICATION TEST SET
K924860 · JJX
Tosoh Medics, Inc.
Chemistry · 157d
Cleared Mar 04, 1993
OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP
K930185 · CEP
Princeton Biomedix
Chemistry · 49d
Cleared Mar 02, 1993
ACCUMETER(R) CHOLESTEROL SELF-TEST
K914432 · CHH
Chemtrak, Inc.
Chemistry · 515d
Cleared Mar 01, 1993
VACUPLUS TUBES WITH GREEN STOPPERS
K924361 · JKA
Starplex Scientific, Inc.
Chemistry · 185d
Cleared Mar 01, 1993
VACUPLUS TUBES WITH LAVANDER STOPPERS
K924362 · JKA
Starplex Scientific, Inc.
Chemistry · 185d
Cleared Mar 01, 1993
VACUPLUS TUBES WITH GREY STOPPERS
K924364 · JKA
Starplex Scientific, Inc.
Chemistry · 185d
Cleared Mar 01, 1993
ACCESS HTSH ASSAY
K925637 · JLW
Bio-Rad Laboratories, Inc.
Chemistry · 112d
Cleared Mar 01, 1993
NAT. SCREENING INSTITUTE MICRO-PLATE FREE T4 ASSAY
K925649 · CEC
Solarcare Technologies Corp,Inc.
Chemistry · 112d
Cleared Feb 25, 1993
TRIODOTHYRONINE (TC) COATED TUBE RIA
K926345 · CDP
Monobind
Chemistry · 70d
Cleared Feb 23, 1993
EXPRESSO CARTRIDGE
K923316 · JQP
Bio-Rad Laboratories, Inc.
Chemistry · 231d
Cleared Feb 23, 1993
STAT PROFILE 9 ANALYZER
K924497 · CHL
Nova Biomedical Corp.
Chemistry · 172d
Cleared Feb 23, 1993
SYSTEMATE PLUS CALIBRATOR
K925101 · JIX
Em Diagnostic Systems, Inc.
Chemistry · 138d
Cleared Feb 23, 1993
HI CHEM ELECTROLYTE REFERENCE REAGENT
K925611 · JGS
Hichem Diagnostics
Chemistry · 110d
Cleared Feb 18, 1993
NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
K925906 · JJX
Analytical Control Systems, Inc.
Chemistry · 90d
Cleared Feb 18, 1993
SYNERMED SINGLE REAGENT CREATININE KIT
K926511 · CGX
Synermed, Inc.
Chemistry · 50d