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
6337–6360 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 27, 1992
CREATINE KINASE-MB (CK-MB) REAGENT SET
K915709 · CGS
Tech Intl. Co.
Chemistry · 59d
Cleared Jan 27, 1992
EMIT D.A.U. PHENCYCLIDINE ASSAY
K915728 · LCM
Syva Co.
Chemistry · 38d
Cleared Jan 22, 1992
IL TEST(TM) CALIBRATION SET SP
K914909 · JIX
Instrumentation Laboratory CO
Chemistry · 82d
Cleared Jan 22, 1992
STACKING MICROPLATE WASHER
K915284 · JQW
Denley Instruments, Inc.
Chemistry · 58d
Cleared Jan 22, 1992
INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET
K915708 · CEO
Tech Intl. Co.
Chemistry · 54d
Cleared Jan 15, 1992
HY-PREP SYSTEM
K913809 · JQW
Hyperion, Inc.
Chemistry · 142d
Cleared Jan 15, 1992
DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200)
K914429 · JKR
Diagnostic Systems Laboratories, Inc.
Chemistry · 103d
Cleared Jan 15, 1992
ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT
K914756 · JLW
Medix Biotech, Inc.
Chemistry · 85d
Cleared Jan 15, 1992
NOVA 4 NA/K/C1/TCO2/LI ANALYZER
K915176 · JGS
Nova Biomedical Corp.
Chemistry · 61d
Cleared Jan 15, 1992
ABBOTT QUICKSTART TIGLYCERIDES REAGENT
K915732 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Jan 09, 1992
LIQUICHEK(R) UNASSAYED CHEMISTRY CONTR(HUMAN) 1&2
K914255 · JJY
Bio-Rad
Chemistry · 108d
Cleared Jan 09, 1992
IL TEST(TM) HDL CHOLESTEROL
K914811 · LBR
Instrumentation Laboratory CO
Chemistry · 76d
Cleared Jan 09, 1992
DSL INSULIN RIA (DSL 1600)
K914820 · CFP
Diagnostic Systems Laboratories, Inc.
Chemistry · 76d
Cleared Jan 08, 1992
VACUTAINER KIT
K914901 · GIM
Abbott Laboratories
Chemistry · 68d
Cleared Jan 08, 1992
DMI BLOD GAS ANALYZER/CARTRIDGE
K915087 · CHL
Diamond Medical, Inc.
Chemistry · 57d
Cleared Jan 08, 1992
CORVAC BLOOD COLLECTION TUBE
K915213 · GIM
Sherwood Medical Co.
Chemistry · 51d
Cleared Jan 07, 1992
ORS-1000
K915427 · JRM
Mnlase, Inc.
Chemistry · 36d
Cleared Jan 03, 1992
ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42
K914463 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Jan 02, 1992
BIO-RAD TOTAL PROTEIN TEST KIT
K913315 · CEF
Bio-Rad
Chemistry · 161d
Cleared Jan 02, 1992
QUALICHECK 4
K915399 · JJS
Radiometer America, Inc.
Chemistry · 34d
Cleared Dec 31, 1991
QUICKSTART UREA NITROGEN
K914903 · CDN
Em Diagnostic Systems, Inc.
Chemistry · 60d
Cleared Dec 23, 1991
ADVANCE(R) PREGNANCY TEST
K914990 · LCX
Ortho Pharmaceutical Corp.
Chemistry · 46d
Cleared Dec 18, 1991
URIC ACID (URICASE) REAGENT, UNIVERSAL
K912028 · KNK
Enzyme Technology, Inc.
Chemistry · 224d
Cleared Dec 18, 1991
ABBOTT QUICKSTART CHOLESTEROL TEST
K913565 · CHH
Em Diagnostic Systems, Inc.
Chemistry · 131d