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
7729–7752 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 03, 1988
DELFIA(TM) NEONATAL HTSH KIT
K881627 · JLW
Pharmacia, Inc.
Chemistry · 174d
Cleared Oct 03, 1988
QTEST PREGNANCY TEST CONTROL
K883741 · JJX
Quidel Corp.
Chemistry · 32d
Cleared Sep 30, 1988
AMERLITE FREE THYROID CONTROL SERA LAN.4002
K883124 · JJY
Amersham Corp.
Chemistry · 66d
Cleared Sep 30, 1988
ISOFOR-MM (TM)
K883222 · JHW
Intl. Immunoassay Laboratories, Inc.
Chemistry · 63d
Cleared Sep 30, 1988
CHECK-MM
K883223 · JHS
Intl. Immunoassay Laboratories, Inc.
Chemistry · 63d
Cleared Sep 30, 1988
RAPIDTEST-HCG (TM)
K883235 · DHA
Synbiotics Corp.
Chemistry · 60d
Cleared Sep 27, 1988
MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE
K883320 · JKA
Sherwood Medical Co.
Chemistry · 53d
Cleared Sep 22, 1988
AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT
K882907 · JLW
Amersham Corp.
Chemistry · 72d
Cleared Sep 22, 1988
AVL MODEL 986 ELECTROLYTE ANALYZER
K883240 · CEM
Avl Scientific Corp.
Chemistry · 52d
Cleared Sep 22, 1988
QUIDEL PREGNANCY TEST CONTROL
K883316 · JJX
Quidel Corp.
Chemistry · 48d
Cleared Sep 19, 1988
SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE
K883181 · CKA
Beckman Instruments, Inc.
Chemistry · 54d
Cleared Sep 19, 1988
ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY
K883395 · JJT
Quantimetrix Medical Industries
Chemistry · 39d
Cleared Sep 19, 1988
COULTER VISCOMETER II
K883503 · JJL
Coulter Electronics, Inc.
Chemistry · 33d
Cleared Sep 13, 1988
TECHNICON RA-100(TM) SYSTEM
K883209 · JJE
Technicon Instruments Corp.
Chemistry · 46d
Cleared Sep 13, 1988
LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL
K883247 · JJY
Quantimetrix Medical Industries
Chemistry · 42d
Cleared Sep 13, 1988
PRL-QUANT
K883269 · CFT
Leeco Diagnostics, Inc.
Chemistry · 41d
Cleared Sep 13, 1988
EMAX PRECISION MICROPLATE READER
K883302 · JJQ
Molecular Devices Corp.
Chemistry · 40d
Cleared Sep 13, 1988
VENTREX COATED TUBE TSH
K883342 · JLW
Ventrex Laboratories, Inc.
Chemistry · 35d
Cleared Sep 13, 1988
IQ HDL CHOLESTEROL
K883353 · LBR
Bd Becton Dickinson Vacutainer...
Chemistry · 35d
Cleared Sep 13, 1988
URIC ACID REAGENT (PRODUCT #88219)
K883404 · KNK
Hichem Diagnostics
Chemistry · 33d
Cleared Sep 13, 1988
TRIGLYCERIDES REAGENT (PRODUCT #88218)
K883405 · CDT
Hichem Diagnostics
Chemistry · 33d
Cleared Sep 13, 1988
BIOTROL URIC ACID ENZYMATIQUE TRINDER
K883428 · KNK
Biotrol, USA, Inc.
Chemistry · 29d
Cleared Sep 13, 1988
DURAZYME(R) CPK
K883504 · CGS
American Monitor Corp.
Chemistry · 27d
Cleared Sep 09, 1988
PREGNAGEN(TM)
K882002 · JHI
Biogenex Laboratories
Chemistry · 119d