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
5593–5616 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Apr 06, 1994
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
K940549 · CEP
Bio-Rad Laboratories, Inc.
Chemistry · 58d
Cleared Apr 05, 1994
SYNERMED ISE REAGENTS
K940194 · JGS
Synermed, Inc.
Chemistry · 82d
Cleared Apr 05, 1994
DOCUMENT(R) ZERO
K940568 · JJX
Casco Standards
Chemistry · 56d
Cleared Apr 04, 1994
TMC I, II
K930534 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 426d
Cleared Mar 28, 1994
ALKO REAGENTS FOR BAXTER PARAMAX CHEMISTRY SYSTEM
K934607 · JIX
Alko Diagnostic Corp.
Chemistry · 182d
Cleared Mar 28, 1994
IL1430 BGELECTROLYTE ANALYZER
K935069 · CHL
Instrumentation Laboratory CO
Chemistry · 154d
Cleared Mar 22, 1994
VIDAS T3 ASSAY
K934764 · CDP
Biomerieux Vitek, Inc.
Chemistry · 169d
Cleared Mar 22, 1994
FERTILITY PLUS 1, 2, 3
K935219 · JJY
Ciba Corning Diagnostics Corp.
Chemistry · 147d
Cleared Mar 22, 1994
SYNELISA DHEA-SULFATE
K935469 · JKC
Elias U.S.A., Inc.
Chemistry · 139d
Cleared Mar 22, 1994
ACA PLUS FERRITIN CALIBRATOR
K935543 · JIX
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 126d
Cleared Mar 22, 1994
SERUM AMMONIA CONTROL
K935606 · JJX
P.T. Meditrol
Chemistry · 123d
Cleared Mar 22, 1994
VIDAS T UPTAKE
K935816 · KHQ
Biomerieux Vitek, Inc.
Chemistry · 110d
Cleared Mar 21, 1994
KODAK EKTACHEM DT SLIDES (URCR)
K934071 · CGX
Eastman Kodak Company
Chemistry · 213d
Cleared Mar 21, 1994
KODAK EKTACHEM DT SLIDES (FE)
K934358 · JQE
Eastman Kodak Company
Chemistry · 194d
Cleared Mar 11, 1994
SIGMA CALCIUM REAGENT
K933678 · CJY
Sigma Chemical Co.
Chemistry · 225d
Cleared Mar 11, 1994
CREATININE-S ASSAY
K934587 · CGX
Diagnostic Chemicals , Ltd.
Chemistry · 169d
Cleared Mar 11, 1994
URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR
K934843 · JIT
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 154d
Cleared Mar 11, 1994
URINARY ALBUMIN CALIBRATOR
K936201 · JIS
Dupont Medical Products
Chemistry · 72d
Cleared Mar 11, 1994
VALPROIC ACID
K936208 · LEG
Seradyn, Inc.
Chemistry · 72d
Cleared Mar 11, 1994
DMA AMYLASE (DEMAND) PROCEDURE
K940010 · CIJ
Data Medical Associates, Inc.
Chemistry · 66d
Cleared Mar 11, 1994
ACS O DILVENT PROTEIN DILUTION MATRIX
K940397 · JJY
Analytical Control Systems, Inc.
Chemistry · 43d
Cleared Mar 09, 1994
REAGENTS FOR HITACHI ISE
K933383 · JIX
Alko Diagnostic Corp.
Chemistry · 270d
Cleared Mar 03, 1994
CEDIA T4 MAB ASSAY MODIFICATION
K935880 · KLI
Microgenics Corp.
Chemistry · 87d
Cleared Mar 03, 1994
ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY
K940005 · CGJ
Bio-Rad Laboratories, Inc.
Chemistry · 59d