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
6601–6624 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 12, 1991
SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483
K910639 · CJE
Em Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Apr 12, 1991
SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476
K910640 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 58d
Cleared Apr 12, 1991
LH IRMA IMMUNOMAG
K911050 · CEP
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 35d
Cleared Apr 08, 1991
SYNCHRON LACTATE REAGENT
K910534 · KHP
Beckman Instruments, Inc.
Chemistry · 59d
Cleared Apr 08, 1991
ENZYMUN-TEST PROGESTERONE
K910683 · JLS
Boehringer Mannheim Corp.
Chemistry · 48d
Cleared Apr 03, 1991
SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER
K910185 · JJE
Beckman Instruments, Inc.
Chemistry · 78d
Cleared Apr 03, 1991
GEM-PREMIER SYSTEM
K910305 · JGS
Mallinckrodt Sensor Systems, Inc.
Chemistry · 69d
Cleared Apr 03, 1991
MICROZYME TSH ENZYME IMMUNOASSAY KIT
K910411 · JLW
Immunotech Corp.
Chemistry · 64d
Cleared Apr 03, 1991
GLUCOSE V
K910573 · CGA
Caro Med, Inc.
Chemistry · 51d
Cleared Apr 03, 1991
IL THEOPHYLLINE ASSAY SYSTEM
K910697 · KLS
Instrumentation Laboratory CO
Chemistry · 43d
Cleared Apr 03, 1991
CIBA CORNING ACS CKMB IMMUNOASSAY
K911121 · JHX
Ciba Corning Diagnostics Corp.
Chemistry · 22d
Cleared Apr 01, 1991
CLEARVIEW HCG
K910946 · JHJ
Unipath , Ltd.
Chemistry · 26d
Cleared Mar 29, 1991
PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION
K910309 · JIX
Baxter Healthcare Corp
Chemistry · 64d
Cleared Mar 29, 1991
BIO SCAN-BG(TM
K910692 · CGA
Bio Scan Instrument, Inc.
Chemistry · 38d
Cleared Mar 29, 1991
CHOLESTEROL CALIBRATOR SET
K910962 · JIT
Casco Standards
Chemistry · 23d
Cleared Mar 27, 1991
SLT MICROPLATE WASHER
K910740 · JJQ
Tecan U.S., Ltd.
Chemistry · 34d
Cleared Mar 21, 1991
IMMUNOCORP COATED TUBE IRMA HCG
K910349 · JHI
Immunocorp
Chemistry · 51d
Cleared Mar 21, 1991
MINICLINIC OVULATION PREDICTION TEST
K910351 · CEP
Vanguard Biomedical Corp.
Chemistry · 65d
Cleared Mar 19, 1991
CHEMTRAK ACCUMETER CHOLESTEROL TEST
K905405 · CHH
Chemtrak, Inc.
Chemistry · 106d
Cleared Mar 19, 1991
PANTEX IRMA LH 1251 KIT
K910717 · CEP
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 27d
Cleared Mar 13, 1991
RENALYZER PRX 90
K903034 · CGL
Swedish Trade Council USA
Chemistry · 245d
Cleared Mar 11, 1991
CHEMA CHOL CHOLESTEROL SYSTEM
K904031 · CHH
Texas Intl. Laboratories, Inc.
Chemistry · 192d
Cleared Mar 11, 1991
GLUCOSE (HK) REAGENT, UNIVERSAL
K905227 · CFR
Enzyme Technology, Inc.
Chemistry · 111d
Cleared Mar 11, 1991
BIOTROL LACTATE DEHYDROGENASE (L-P)
K905683 · CFJ
Biotrol, USA, Inc.
Chemistry · 82d