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.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,249 results
12337–12360 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
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
Cleared May 03, 1979
T-3 UPTAKE (MAA) KIT
K790461 · KHQ
Amersham Corp.
Chemistry · 59d
Cleared May 03, 1979
COULTER ACCU-ZYME II GOT REAGENT
K790483 · CIT
Coulter Electronics, Inc.
Chemistry · 55d
Cleared May 03, 1979
AMYLOCHROME STAT SEPARATOR, TEST
K790485 · JKA
Hoffmann-La Roche, Inc.
Chemistry · 52d
Cleared May 03, 1979
THYROXINE RIA KIT
K790495 · CDX
Technia Diagnostics , Ltd.
Chemistry · 51d
Cleared May 03, 1979
THE ABBOTT EXECUTIVE
K790543 · JQP
Abbott Laboratories
Chemistry · 42d
Cleared May 03, 1979
HEATING BLOCK, WAMPOLE 37 C
K790549 · JRG
Armkel, LLC
Chemistry · 44d