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
9889–9912 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 22, 1984
REFLOCHECK-S
K840962 · CGA
Boehringer Mannheim Corp.
Chemistry · 108d
Cleared Jun 22, 1984
DIAGNON FOLATE 125I RIA KIT
K841302 · CGN
Diagnon Corp.
Chemistry · 84d
Cleared Jun 22, 1984
ELECTROLYTE ANALYZER SERA-210
K841424 · JGS
Horiba Instruments, Inc.
Chemistry · 77d
Cleared Jun 22, 1984
NOVA STAT CONTROL LEVELS 1/2/3
K841452 · JJY
Nova Biomedical Corp.
Chemistry · 74d
Cleared Jun 22, 1984
CHANGES IN THE CHEMICAL COMP. OF 5
K841464 · JIX
Nova Biomedical Corp.
Chemistry · 102d
Cleared Jun 22, 1984
CA-1511, IN VITRO RADIOIMMUNOASSAY
K841821 · JHI
Travenol Laboratories, S.A.
Chemistry · 51d
Cleared Jun 22, 1984
PREG-BETA ONE HOUR TUBE TEST
K841853 · JHJ
Intl. Diagnostic, Inc.
Chemistry · 50d
Cleared Jun 22, 1984
BHCG RIA
K841854 · JHI
Syncor Intl. Corp.
Chemistry · 50d
Cleared Jun 22, 1984
PARAMAX IRON REAGENT
K841886 · JIY
American Dade
Chemistry · 46d
Cleared Jun 22, 1984
PARAMAX IRON BLANK REAGENT
K841887 · JIY
American Dade
Chemistry · 46d
Cleared Jun 22, 1984
ABBOTT PROJECT I
K841916 · JJE
Abbott Laboratories
Chemistry · 44d
Cleared Jun 22, 1984
CHLORIDE TEST KIT
K842011 · CHJ
Mallinckrodt Critical Care
Chemistry · 36d
Cleared Jun 22, 1984
TIBC PRETREATMENT KIT
K842019 · JQE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 35d
Cleared Jun 22, 1984
ION 4 SODIUM/POTASSIUM/CHLORIDE/TOTAL
K842025 · JGS
Hi Chem, Inc.
Chemistry · 35d
Cleared Jun 22, 1984
ELVI 165 PROTEO SEROSKOP
K842056 · JQT
Logos Scientific, Inc.
Chemistry · 31d
Cleared Jun 14, 1984
UREA NITROGEN REAGENT SET
K840064 · CDQ
Sterling Biochemical, Inc.
Chemistry · 157d
Cleared Jun 14, 1984
RIANEN CYCLIC-AMP RADIOIMMUNOASSAY
K841478 · CHO
New England Nuclear
Chemistry · 66d
Cleared Jun 14, 1984
BLOOD GAS CONTROL, LEVEL I(ACIDOSIS
K841783 · JJS
Bionostics, Inc.
Chemistry · 45d
Cleared Jun 14, 1984
SIGMS PROCED. 228 UV LACTATE DEHYDRO
K841917 · CFJ
Sigma Diagnostics, Inc.
Chemistry · 36d
Cleared Jun 14, 1984
SIGMA PROCED. 245 ALKALINE PHOSPHATASE
K841918 · CJE
Sigma Diagnostics, Inc.
Chemistry · 36d
Cleared Jun 11, 1984
HEPARINOMETER
K834024 · KFF
Western Laboratories Corp.
Chemistry · 202d
Cleared Jun 11, 1984
AUTOMATED EIA MICROPLATE READER EL310
K842085 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 18d
Cleared Jun 08, 1984
ENZYMATIC CO2 DIAGNOSTIC CHEMICAL
K841664 · KHS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 46d
Cleared Jun 08, 1984
TDX REA LDH
K841703 · CFJ
Abbott Laboratories
Chemistry · 46d