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
6529–6552 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jul 17, 1991
NOVA 12 ANALYZER
K912560 · JGS
Nova Biomedical Corp.
Chemistry · 36d
Cleared Jul 17, 1991
SYNERMED PHOSPHORUS REAGENT KIT
K912569 · CEO
Synermed, Inc.
Chemistry · 36d
Cleared Jul 17, 1991
ISE/CI-
K912647 · CGZ
Boehringer Mannheim Corp.
Chemistry · 30d
Cleared Jul 17, 1991
ISE/NA+
K912648 · JGS
Boehringer Mannheim Corp.
Chemistry · 30d
Cleared Jul 17, 1991
AMERLITE CK-MB ASSAY
K912766 · JHY
Amersham Corp.
Chemistry · 23d
Cleared Jul 15, 1991
ISE/K+
K912649 · CEM
Boehringer Mannheim Corp.
Chemistry · 28d
Cleared Jul 08, 1991
PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT
K912231 · JHW
Intl. Immunoassay Laboratories, Inc.
Chemistry · 49d
Cleared Jul 01, 1991
KETOSITE(TM)/STAT-SITE(TM)/KETOSITE(TM) LOW-HI CON
K911801 · JIN
Gds Technology, LLC
Chemistry · 69d
Cleared Jul 01, 1991
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K912217 · DIH
Eastman Kodak Company
Chemistry · 42d
Cleared Jul 01, 1991
KETO-340 II
K912373 · JIN
Ihara Medics U.S., Inc.
Chemistry · 33d
Cleared Jul 01, 1991
I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK
K912387 · JGS
I-Stat Corp.
Chemistry · 61d
Cleared Jul 01, 1991
CHEM-LINK DATA BASE MANAGER
K912413 · JJQ
Technicon Instruments Corp.
Chemistry · 31d
Cleared Jul 01, 1991
AMYLASE REAGENT
K912519 · JFJ
Genzyme Corp.
Chemistry · 25d
Cleared Jul 01, 1991
IMX HCG
K912534 · JHI
Abbott Laboratories
Chemistry · 24d
Cleared Jul 01, 1991
IMX TOTAL B-HCG
K912535 · JHI
Abbott Laboratories
Chemistry · 24d
Cleared Jul 01, 1991
NOVA 1 SODIUM/POTASSIUM/HEMATOCRIT ANALYZER
K912559 · JGS
Nova Biomedical Corp.
Chemistry · 20d
Cleared Jun 24, 1991
OBA(TM) READER
K911045 · JJQ
Adeza Biomedical
Chemistry · 108d
Cleared Jun 24, 1991
OBA(TM) SERUM HCG ASSAY
K911047 · JHI
Adeza Biomedical
Chemistry · 108d
Cleared Jun 24, 1991
MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST
K911634 · CEC
Immunotech Corp.
Chemistry · 74d
Cleared Jun 21, 1991
SYRINGE TIP CAP
K911638 · JKA
Concord/Portex
Chemistry · 71d
Cleared Jun 20, 1991
IMMULITE(TM) HCG
K911796 · DHA
Cirrus Diagnostics, Inc.
Chemistry · 59d
Cleared Jun 20, 1991
STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY
K912241 · JLW
Baxter Healthcare Corp
Chemistry · 30d
Cleared Jun 20, 1991
NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY
K912324 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 27d
Cleared Jun 18, 1991
NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT
K911839 · JLX
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 54d