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
9481–9504 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 03, 1985
I-L TEST, DIRECT BILIRUBIN SET
K850748 · CIG
Allied Instrumentation Laboratory
Chemistry · 37d
Cleared Apr 02, 1985
LEECO CONCEP-7-BHCG IRMA
K850530 · JHI
Leeco Diagnostics, Inc.
Chemistry · 50d
Cleared Apr 02, 1985
LEECO CONCEP-7-BHCG EIA
K850531 · JHI
Leeco Diagnostics, Inc.
Chemistry · 50d
Cleared Apr 02, 1985
STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY
K850570 · JHI
American Dade
Chemistry · 48d
Cleared Apr 02, 1985
MODEL SERUM HCG ASSAY
K850730 · JHI
Monoclonal Antibodies, Inc.
Chemistry · 39d
Cleared Apr 02, 1985
DROPSTIRS - PLASTIC DISPOSABLE PIPET
K850800 · JQW
Berwick Medical Products, Inc.
Chemistry · 34d
Cleared Apr 01, 1985
CALIBRATOR B 88133
K850405 · JIX
Hi Chem, Inc.
Chemistry · 56d
Cleared Apr 01, 1985
DATA CHEM AUTO-BILIRUBIN/DIRECT PROCEDURE
K850901 · CIG
Data Medical Associates, Inc.
Chemistry · 27d
Cleared Apr 01, 1985
DATE CHEM INORGANIC PHOSPHOROUS U.V. PROCEDURE
K850986 · CEO
Data Medical Associates, Inc.
Chemistry · 21d
Cleared Mar 29, 1985
URI-VAL
K843680 · JMZ
Cenogenics Corp.
Chemistry · 192d
Cleared Mar 29, 1985
RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI
K850054 · CIB
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 80d
Cleared Mar 29, 1985
ISOENZYME TEST LD-1
K850210 · CFE
Sclavo, Inc.
Chemistry · 73d
Cleared Mar 29, 1985
ICS THEOPHYLLINE REAGENTS
K850856 · KLS
Beckman Instruments, Inc.
Chemistry · 28d
Cleared Mar 26, 1985
SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY
K850787 · CGI
Nms Pharmaceuticals, Inc.
Chemistry · 28d
Cleared Mar 22, 1985
COBAS FP REAGENTS FOR CARBAMAZEPINE
K850807 · KLT
Roche Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Mar 21, 1985
TITERTEK MULTISKAN MCC
K844418 · JJQ
Flow Laboratories, Inc.
Chemistry · 126d
Cleared Mar 21, 1985
TITERTEK MULTISKAN MSS/340
K844419 · JJQ
Flow Laboratories, Inc.
Chemistry · 126d
Cleared Mar 21, 1985
TITERTEK TWINREADER 78-630-00
K844567 · JJQ
Flow Laboratories, Inc.
Chemistry · 118d
Cleared Mar 21, 1985
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS
K845032 · DHB
Pharmacia, Inc.
Chemistry · 84d
Cleared Mar 21, 1985
ENCORE FERRITIN REAGENT
K850680 · JMB
Hybritech, Inc.
Chemistry · 28d
Cleared Mar 21, 1985
ACTH II BY RADIOIMMUNOASSAY
K850882 · CKG
Immuno Nuclear Corp.
Chemistry · 17d
Cleared Mar 20, 1985
DATA ZYME ACID PHOSPHATASE PROCEDURE
K850902 · CKB
Data Medical Associates, Inc.
Chemistry · 15d
Cleared Mar 20, 1985
BUN (RATE) REAGENT
K850923 · CDQ
Sigma Diagnostics, Inc.
Chemistry · 15d
Cleared Mar 19, 1985
SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, &
K844955 · CEM
Miles Laboratories, Inc.
Chemistry · 88d