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
5521–5544 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Jun 21, 1994
AXSYM LUTEINIZING HORMONE (LH)
K935611 · JJX
Abbott Laboratories
Chemistry · 211d
Cleared Jun 21, 1994
AXSYM FOLLICLE STIMULATING HORMONE (FSH)
K935612 · CGJ
Abbott Laboratories
Chemistry · 211d
Cleared Jun 21, 1994
AXSYM TOTAL B-HCG
K935673 · JHI
Abbott Laboratories
Chemistry · 207d
Cleared Jun 21, 1994
AXSYM PROLACTIN
K935675 · CFT
Abbott Laboratories
Chemistry · 207d
Cleared Jun 21, 1994
AXSYM CK-MB
K935924 · JHW
Abbott Laboratories
Chemistry · 190d
Cleared Jun 21, 1994
AXSYM(TM) QUINIDINE
K940682 · LGI
Abbott Laboratories
Chemistry · 131d
Cleared Jun 16, 1994
DSL ESTRONE (DSL 8700)
K935013 · CGF
Diagnostic Systems Laboratories, Inc.
Chemistry · 239d
Cleared Jun 13, 1994
UA PERFECT
K935408 · KQO
Chimera Research & Chemical, Inc.
Chemistry · 216d
Cleared Jun 13, 1994
GLUCOMETER ELITE LOW CONTROL
K940577 · JJX
Heraeus Kulzer, Inc.
Chemistry · 125d
Cleared Jun 13, 1994
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN
K941142 · DIP
Eastman Kodak Company
Chemistry · 95d
Cleared Jun 03, 1994
ASSURE URINE HCG CONTROL
K941130 · JJX
Quantimetrix Corp.
Chemistry · 86d
Cleared Jun 03, 1994
DUPONT ACA PLUS PROLACTIN (PROL) METHOD
K941220 · CFT
Dupont Medical Products
Chemistry · 81d
Cleared Jun 03, 1994
STAT FAX 2600
K941394 · JQW
Awareness Technology, Inc.
Chemistry · 73d
Cleared Jun 02, 1994
APOLIPOPROTIEN B (APO B)
K932603 · JHN
Sigma Diagnostics, Inc.
Chemistry · 370d
Cleared Jun 02, 1994
APOLIPOPROTIEN A-1 (APO A-1)
K932606 · JHN
Sigma Diagnostics, Inc.
Chemistry · 370d
Cleared Jun 02, 1994
LIPASE REAGENT SYSTEM
K940457 · CET
Medical Diagnostic Technologies, Inc.
Chemistry · 121d
Cleared Jun 02, 1994
PREDICTOR HOME PREGNANCY TEST
K940637 · LCX
Organon Teknika Corp.
Chemistry · 108d
Cleared Jun 02, 1994
UNISTEP HCG PREGNANCY TEST STRIP
K941090 · DHA
Biotech Atlantic, Inc.
Chemistry · 86d
Cleared Jun 02, 1994
ACCESS PROLACTIN
K941175 · CFT
Bio-Rad Laboratories, Inc.
Chemistry · 80d
Cleared May 27, 1994
ABL SYSTEM 620
K935121 · CHL
Radiometer America, Inc.
Chemistry · 212d
Cleared May 27, 1994
ABL5 BLOOD GAS SYSTEM
K935655 · CHL
Radiometer America, Inc.
Chemistry · 184d
Cleared May 27, 1994
ULTRAFREE-CL
K941326 · JJH
Millipore Corp.
Chemistry · 70d
Cleared May 24, 1994
SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY
K941497 · CKA
Solarcare, Inc.
Chemistry · 57d
Cleared May 23, 1994
AUTO DELFIA
K935047 · KHO
Wallac OY
Chemistry · 214d