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
13081–13104 of 13,249
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Feb 24, 1977
ALKALINE PHOSPHATASE (ALP)/PNPP
K761315 · CJE
Princeton Biomedix
Chemistry · 63d
Cleared Feb 23, 1977
GO/HPO-GLUCOSE REAGENT (TRINDER)
K770200 · CGA
Beckman Instruments, Inc.
Chemistry · 23d
Cleared Feb 23, 1977
GLUCOSE (HEXOKINASE) DELTA TEST ASSAY
K770262 · CFR
Bd Becton Dickinson Vacutainer...
Chemistry · 12d
Cleared Feb 23, 1977
LDH-L TEST
K770267 · CFJ
Sclavo, Inc.
Chemistry · 12d
Cleared Feb 22, 1977
REAGENT SYSTEM
K770242 · CGX
American Monitor Corp.
Chemistry · 15d
Cleared Feb 14, 1977
URIN. L7-OH CORTICOSTEROID T(NON HYDRO)
K761271 · CDB
Eppendorf-Brinkmann, Inc.
Chemistry · 56d
Cleared Feb 14, 1977
AUTO CREATININE REAGENT (GILFORD 3400-E)
K761280 · CGX
Harleco
Chemistry · 56d
Cleared Feb 11, 1977
REFLOMAT/REFLOTEST SYSTEM
K761148 · CGA
Boehringer Mannheim Corp.
Chemistry · 77d
Cleared Feb 11, 1977
AUTO CREATININE REAGENT (ABBOTT SYSTEM)
K761279 · CGX
Harleco
Chemistry · 53d
Cleared Feb 11, 1977
SMA REFERENCE SERUM 3
K770142 · JIX
Technicon Instruments Corp.
Chemistry · 18d
Cleared Feb 09, 1977
DATA-TOPE T3 UPTAKE PROCEDURE
K761281 · KHQ
Dade, Baxter Travenol Diagnostics, Inc.
Chemistry · 51d
Cleared Feb 01, 1977
SMA MICROLYZER
K761342 · JJC
Technicon Instruments Corp.
Chemistry · 35d
Cleared Jan 31, 1977
MANUEL BILIRUBIN REAGENT SET
K770121 · CIG
Harleco
Chemistry · 10d
Cleared Jan 31, 1977
CENTRIFICHEM CHOLES. CALIB. STD. SET
K770126 · JIT
Union Carbide Corp.
Chemistry · 10d
Cleared Jan 31, 1977
CENTRIFICHEM 200MG/DL CHOL. CAL. STD.
K770127 · JIT
Union Carbide Corp.
Chemistry · 10d
Cleared Jan 31, 1977
ALKALINE PHOSPHATASE ISOYZME REAGENT SET
K770155 · CJO
Gelman Instrument Co.
Chemistry · 7d
Cleared Jan 31, 1977
MICRO-MIX PIPETTE SHAKER
K770165 · JRQ
Maddak, Inc.
Chemistry · 6d
Cleared Jan 26, 1977
GLUCOSE ANALYZER 2 W/ CHOLES. REAG KT
K761136 · CHH
Beckman Instruments, Inc.
Chemistry · 63d
Cleared Jan 26, 1977
FLOUROMETER/DENSITOMETER MODEL 720
K770026 · JQT
Corning Medical & Scientific
Chemistry · 20d
Cleared Jan 26, 1977
LDH ISOTROL T
K770049 · JJT
Sigma Chemical Co.
Chemistry · 16d
Cleared Jan 26, 1977
GDH-GLUCOSE (RATE) REAGENT KIT
K770062
Beckman Instruments, Inc.
Chemistry · 15d
Cleared Jan 26, 1977
BIO TROL-T TRIOLEIN SOLUTIONS
K770072 · JIS
Boehringer Mannheim Corp.
Chemistry · 13d
Cleared Jan 25, 1977
GLUCOSE ANALYZER 2
K761060 · CGA
Beckman Instruments, Inc.
Chemistry · 68d
Cleared Jan 25, 1977
BLOOD-UREA-NITROGEN (BUN) ANALYZER 2
K761061 · CDS
Beckman Instruments, Inc.
Chemistry · 68d