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
6217–6240 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 09, 1992
LIQUICHEK LIPIDS CONTROL LEVELS 1 AND 2
K921286 · JJY
Bio-Rad
Chemistry · 84d
Cleared Jun 09, 1992
ORS-100
K921568 · JRM
Mnlase, Inc.
Chemistry · 68d
Cleared Jun 09, 1992
ORS-200
K921569 · JRM
Mnlase, Inc.
Chemistry · 68d
Cleared Jun 09, 1992
ORS-300
K921570 · JRM
Mnlase, Inc.
Chemistry · 68d
Cleared Jun 09, 1992
CIBA CORNING ACS FOLATE IMMUNOASSAY
K921678 · JIX
Ciba Corning Diagnostics Corp.
Chemistry · 62d
Cleared Jun 09, 1992
IMMULITE(R) FSH
K921704 · CGJ
Cirrus Diagnostics, Inc.
Chemistry · 60d
Cleared Jun 09, 1992
TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
K921763 · JHY
Hybritech, Inc.
Chemistry · 56d
Cleared Jun 04, 1992
CEDIA FERRITIN ASSAY
K920318 · JMG
Microgenics Corp.
Chemistry · 132d
Cleared Jun 04, 1992
KING DIAGNOSTICS ALT (GPT) REAGENT
K922109 · CKA
King Diagnostics, Inc.
Chemistry · 30d
Cleared May 29, 1992
SYNTRON QUIKSTRIP/E.Z. STRIP PREGNANCY HOME TEST
K921099 · LCX
Syntron Bioresearch, Inc.
Chemistry · 81d
Cleared May 28, 1992
DIRECTDRAW SUPERSERUM
K921778 · GIM
International Technidyne Corp.
Chemistry · 44d
Cleared May 26, 1992
DSL DHEA (DSL 8900)
K921534 · JKL
Diagnostic Systems Laboratories, Inc.
Chemistry · 56d
Cleared May 26, 1992
BIOTROL MAGNESIUM (MAGON)
K921677 · JGJ
Biotrol, USA, Inc.
Chemistry · 48d
Cleared May 26, 1992
THYROXINE CALIBRATOR KIT
K921903 · JIS
Tudor Laboratories, Inc.
Chemistry · 35d
Cleared May 14, 1992
N-TACT(R) PTH SP KIT
K921629 · CEW
Incstar Corp.
Chemistry · 38d
Cleared May 13, 1992
CALCIUM-ARSENAZO III REAGENT SET
K921625 · CIC
Pointe Scientific, Inc.,
Chemistry · 37d
Cleared May 07, 1992
IMX INSULIN
K920109 · CFP
Abbott Laboratories
Chemistry · 118d
Cleared May 07, 1992
KEMTROL SERUM CONTROL-ABNORMAL
K920926 · JJY
Helena Laboratories
Chemistry · 69d
Cleared May 07, 1992
SYNERMED ALT/GPT REAGENT KIT
K921016 · CKA
Synermed, Inc.
Chemistry · 65d
Cleared May 07, 1992
NOW PREGNANCY TEST KIT
K921211 · JHI
Bio Clinic Co.
Chemistry · 56d
Cleared May 07, 1992
MIRCO ELISA HPL TEST KIT
K921212 · JHI
Bio Clinic Co.
Chemistry · 56d
Cleared May 04, 1992
MICROLITE MICROTITER PLATE LUMINOMETER ML2250/MODI
K915896 · JJQ
Dynatech Laboratories, Inc.
Chemistry · 137d
Cleared Apr 29, 1992
ELECTRODE, ION SPECIFIC
K915675 · JFP
Alko Diagnostic Corp.
Chemistry · 132d
Cleared Apr 29, 1992
ROCHE COBAS MIRA PLUS
K920402 · JJE
Roche Diagnostic Systems, Inc.
Chemistry · 89d