FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,231 results
12313–12336 of 13,231
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 15, 1979
GLUCOSE (HK) REAGENT
K790786 · CFR
Gilford Diagnostics
Chemistry · 53d
Cleared Jun 15, 1979
ELECTROPHORESIS REAGENT SET, HDL
K790791 · LBT
Gelman Sciences, Inc.
Chemistry · 52d
Cleared Jun 05, 1979
FETAL MATURITY TEST PROCEDURE
K790798 · JHG
Helena Laboratories
Chemistry · 49d
Cleared May 25, 1979
RIA KIT, PROSTATIC ACID
K790580 · JFH
Monitor Science Corp.
Chemistry · 59d
Cleared May 25, 1979
EMIT CFA THYROXINE ASSAY
K790686 · KLI
Syva Co.
Chemistry · 44d
Cleared May 23, 1979
CONCEP-7-B-HCG
K790397 · JHI
Leeco Diagnostics, Inc.
Chemistry · 86d
Cleared May 23, 1979
DATA-ZYME ACIA PHOSPHATASE PROCEDURE
K790524 · CKE
Data Medical Associates, Inc.
Chemistry · 69d
Cleared May 23, 1979
CENTRIFICHEM FILTER CALIBRATION SET
K790643 · JIW
Union Carbide Corp.
Chemistry · 54d
Cleared May 23, 1979
ESTRADIOL RIA KIT
K790679 · CHP
Serono Laboratories, Inc.
Chemistry · 44d
Cleared May 23, 1979
ENZYMATIC DETERMINATION
K790724 · CHH
Sigma Chemical Co.
Chemistry · 40d
Cleared May 23, 1979
REAGENT SYSTEM #350HDL, SIGMA PROCEDURE
K790760 · CHH
Sigma Chemical Co.
Chemistry · 36d
Cleared May 23, 1979
WAKO CHOLESTEROL TEST
K790768 · CHH
Wako Intl., Inc.
Chemistry · 34d
Cleared May 15, 1979
ROCHE LACTATE ANALYZER 640
K790421 · KHP
Roche Medical Electronics, Inc.
Chemistry · 76d
Cleared May 15, 1979
GAMMA SMAC REAGENTS
K790578 · CIG
Gamma Enterprises, Inc.
Chemistry · 49d
Cleared May 15, 1979
CHROMATOGRAPHY TUBES
K790581 · CDP
Miles Laboratories, Inc.
Chemistry · 49d
Cleared May 15, 1979
CENTRIFICHEM INORGANIC PHOSPHORUS
K790662 · CED
Union Carbide Corp.
Chemistry · 39d
Cleared May 15, 1979
NEONATAL TY AUTOPAK TEST DELIVERY SYSTEM
K790665 · CDX
Micromedic Systems
Chemistry · 39d
Cleared May 15, 1979
LD-P REAGENT (LDH P-L REAGENT)
K790771 · CFJ
Gilford Diagnostics
Chemistry · 25d
Cleared May 07, 1979
PAP RIA KIT
K790317 · JFH
Yang Laboratories, Inc.
Chemistry · 81d
Cleared May 07, 1979
CENTRIA SYSTEM
K790550 · JJG
Union Carbide Corp.
Chemistry · 48d
Cleared May 07, 1979
CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC
K790556 · CHH
Calbiochem-Behring Corp.
Chemistry · 49d
Cleared May 07, 1979
RIA KIT, QUANTITATION OF PROSTATIC ACID
K790817 · JFH
New England Nuclear
Chemistry · 10d
Cleared May 03, 1979
H-D-EL
K790372 · LBR
General Diagnostics
Chemistry · 69d
Cleared May 03, 1979
PROGESTERONE
K790440 · JLS
Serono Laboratories, Inc.
Chemistry · 57d