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
6409–6432 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 23, 1991
SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS)
K914462 · JLS
Serono-Baker Diagnostics, Inc.
Chemistry · 16d
Cleared Oct 21, 1991
LIPASE LINEARITY CONTROL
K913585 · JJX
Creative Laboratory Products, Inc.
Chemistry · 70d
Cleared Oct 21, 1991
ABBOTT QUICKSTART LD-1,#5A30
K914261 · JGF
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Oct 18, 1991
DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM
K913967 · KDW
Doxtech, Inc.
Chemistry · 43d
Cleared Oct 17, 1991
HOMECLINIC ONE STEP PREGNANCY TEST
K914254 · LCX
Vanguard Biomedical Corp.
Chemistry · 24d
Cleared Oct 17, 1991
FIRST RESPONSE(R) ONE-STEP
K914304 · LCX
Armkel, LLC
Chemistry · 22d
Cleared Oct 15, 1991
MARKSMAN ARTERIAL BLOOD GAS SYRINGE
K910970 · JKA
Martech Medical Products, Inc.
Chemistry · 222d
Cleared Oct 11, 1991
URINE/CSF MICROPROTEIN REAGENT
K913225 · CEK
Intersect Systems, Inc.
Chemistry · 84d
Cleared Oct 11, 1991
ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21
K913307 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 78d
Cleared Oct 11, 1991
IL BG3 SYST, MODEL 1420, BLOOD GAS & PH TEST SYST
K913927 · CHL
Instrumentation Laboratory CO
Chemistry · 38d
Cleared Oct 11, 1991
DIFF SAFE
K914129 · JKA
Marshall Levinson
Chemistry · 28d
Cleared Oct 11, 1991
BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE
K914202 · JJQ
Baxter Diagnostics, Inc.
Chemistry · 22d
Cleared Oct 11, 1991
PROCLINIC ONE STEP PREGNANCY TEST
K914253 · JHI
Vanguard Biomedical Corp.
Chemistry · 18d
Cleared Oct 11, 1991
ABBOTT QUICKSTART LDH,#5A31
K914262 · CFJ
Em Diagnostic Systems, Inc.
Chemistry · 18d
Cleared Oct 11, 1991
TARGET(TM)-HOG
K914303 · JHI
V-Tech, Inc.
Chemistry · 16d
Cleared Oct 09, 1991
ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16
K913025 · CJW
Em Diagnostic Systems, Inc.
Chemistry · 92d
Cleared Oct 09, 1991
ABBOTT QLUICKSTART IRON TEST, ITEM #5A29
K913705 · CFM
Em Diagnostic Systems, Inc.
Chemistry · 51d
Cleared Oct 09, 1991
TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZE
K913978 · CEK
Beckman Instruments, Inc.
Chemistry · 33d
Cleared Oct 07, 1991
AFFINITY FREE T4 TEST SYSTEM
K912698 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 111d
Cleared Oct 04, 1991
WELLPREP 1
K913567 · JQW
Denley Instruments, Inc.
Chemistry · 56d
Cleared Oct 02, 1991
YSI MODEL 2300 STAT PLUS
K913806 · CGA
Ysis, Inc.
Chemistry · 37d
Cleared Oct 02, 1991
ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST
K914068 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 21d
Cleared Sep 30, 1991
MEDISENSOR 2001
K903564 · JGS
Medtest Systems, Inc.
Chemistry · 419d
Cleared Sep 30, 1991
AIA-PACK T-U
K913663 · KHQ
Tosoh Corp.
Chemistry · 45d