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
8065–8088 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jan 05, 1988
REFLOTRON (R) AMYLASE
K874704 · JFJ
Boehringer Mannheim Corp.
Chemistry · 47d
Cleared Jan 05, 1988
DC-TROL LEVEL 1 OR 2
K874772 · JJY
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 47d
Cleared Jan 05, 1988
REFERENCE ASSAYED CHEMISTRY CONTROL SERUM
K874810 · JJY
Biotrol, USA, Inc.
Chemistry · 43d
Cleared Jan 05, 1988
BIOTROL BICARBONATE (CO2) UV HP)
K874941 · KHS
Biotrol, USA, Inc.
Chemistry · 34d
Cleared Dec 30, 1987
IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5
K874032 · CEP
Diagnostic Products Corp.
Chemistry · 89d
Cleared Dec 29, 1987
LIQUI-SERA SPINAL FLUID CONTROL
K874459 · JJY
Biodiagnostic Intl
Chemistry · 61d
Cleared Dec 22, 1987
FRUCTOSAMINE TEST (ROCHE)
K854010 · LCP
Roche Diagnostic Systems, Inc.
Chemistry · 813d
Cleared Dec 22, 1987
GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT
K871835 · CGA
Miles Laboratories, Inc.
Chemistry · 225d
Cleared Dec 22, 1987
HVA & HOMOVANILLIC ACID BY HPLC METHOD
K873372 · CDF
Bio-Rad
Chemistry · 120d
Cleared Dec 22, 1987
INORGANIC PHOSPHORUS
K874472 · CEO
Catachem, Inc.
Chemistry · 50d
Cleared Dec 22, 1987
WAKO(TM) AUTOKIT LIPASE
K874640 · CHI
Wako Chemicals USA, Inc.
Chemistry · 40d
Cleared Dec 22, 1987
EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019
K874705 · JEJ
Em Diagnostic Systems, Inc.
Chemistry · 33d
Cleared Dec 18, 1987
IMACK-MB TEST PROCEDURE (MODIFICATION)
K874545 · JHY
Intl. Immunoassay Laboratories, Inc.
Chemistry · 45d
Cleared Dec 18, 1987
CIBA CORNING T4 LIPIA (LIPOSOME IMMUNOASSAY)
K874603 · KLI
Ciba Corning Diagnostics Corp.
Chemistry · 39d
Cleared Dec 18, 1987
FIAGEN(TM) HTSH CATALOGUE NUMBER: 101-301
K874622 · JLW
Cyberfluor, Inc.
Chemistry · 38d
Cleared Dec 18, 1987
TDXR DELTA-9-CANNABINOIDS
K874646 · LDJ
Abbott Laboratories
Chemistry · 35d
Cleared Dec 18, 1987
TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C)
K874658 · CEE
Technicon Instruments Corp.
Chemistry · 36d
Cleared Dec 18, 1987
EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008
K874708 · LFR
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Dec 18, 1987
MULTICHEM CHLORIDE REAGENT S0933
K874812 · CHJ
Simmler, Inc.
Chemistry · 24d
Cleared Dec 18, 1987
MAGNESIUM
K874847 · JGJ
Tech-Co, Inc.
Chemistry · 24d
Cleared Dec 18, 1987
LACTATE DEHYDROGENASE LDH-L
K874848 · CFJ
Tech-Co, Inc.
Chemistry · 24d
Cleared Dec 14, 1987
PARAMAX CALCIUM REAGENT
K873519 · CIC
Baxter Healthcare Corp
Chemistry · 104d
Cleared Dec 14, 1987
PARAMAX MAGNESIUM REAGENT
K873530 · JGJ
Baxter Healthcare Corp
Chemistry · 104d
Cleared Dec 14, 1987
MEDATRON CUVETTE DISC
K873656 · JRI
Medatron, Inc.
Chemistry · 95d