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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,224 results
11473–11496 of 13,224
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared May 21, 1981
TECHNICON SMAC II SYSTEM & ACCESSORIES
K811249 · JJC
Technicon Instruments Corp.
Chemistry · 16d
Cleared May 21, 1981
CITRATE BUFFER
K811251 · JCC
Bioscientific
Chemistry · 16d
Cleared May 15, 1981
ARIA II INSULIN RIA
K811144 · CFP
Bd Becton Dickinson Vacutainer...
Chemistry · 18d
Cleared May 15, 1981
URINE PREGNANCY TEST STANDARD/CONTR. PK
K811150 · JJX
Mallinckrodt Critical Care
Chemistry · 18d
Cleared May 15, 1981
PROSTATIC ACID PHOSPHATASE (PAP) RDA KIT
K811169 · JFH
Amersham Corp.
Chemistry · 17d
Cleared May 15, 1981
QUANTA PHASE VITAMIN B-12/FOLATE RAD
K811177 · CGN
Bio-Rad
Chemistry · 17d
Cleared May 15, 1981
HUMAN IGG-ALBUMIN TEST KIT
K811178 · CJQ
Meloy Laboratories, Inc.
Chemistry · 17d
Cleared May 15, 1981
OSMOMETER MODEL OM-6010
K811179 · JJM
Fiske Med Science
Chemistry · 17d
Cleared May 15, 1981
MULTIANALYTE CONTROLS, ALL KINDS
K811182 · JJY
Fisher Scientific Co., LLC
Chemistry · 17d
Cleared May 13, 1981
PHADEBAS ISOAMYLASE TEST
K810584 · CIW
Pharmacia, Inc.
Chemistry · 70d
Cleared May 13, 1981
MINIMUM ESSENTIAL MEDIUM EAGLE W/HANKS
K810768 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
MINIMUM ESSENTIAL MEDIUM EAGLE W/EARLE
K810769 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
MED. 199(MODIFIED) W/HANKS' SALTS
K810770 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
L-15 MEDIUM (MODIFIED)
K810771 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
MEDIUM 199 W/EARLE'S SALTS & GLUTAMINE
K810772 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
BASAL MEDIUM EAGLE W/HANKS' SALTS
K810773 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
WATER-TISSUE CULTURE GRADE
K810774 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
PENICILLIN-STREPTOMYCIN MIXTURE
K810776 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
BASAL MEDIUM EAGLE (MOD.) W/EARLE'S SALT
K810778 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
EARLE'S BALANCED SALTS SOULTION
K810779 · KIP
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
SODIUM BICARBONATE (7.5%) SOLUTION
K810780 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
L-GLUTAMINE
K810781 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
TRYPAN BLUE (0.5% IN NORMAL SALINE)
K810782 · LGY
Dutchland Laboratories, Inc.
Chemistry · 51d
Cleared May 13, 1981
ALSEVER'S SOLUTION (MODIFIED)
K810783 · KIT
Dutchland Laboratories, Inc.
Chemistry · 51d