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
4297–4320 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Dec 17, 1997
DBEST ONE-STEP HCG SERUM/URINE TEST
K973957 · JHI
Ameritek, Inc.
Chemistry · 62d
Cleared Dec 17, 1997
IL TEST AMYLASE
K974125 · JFJ
Instrumentation Laboratory CO
Chemistry · 44d
Cleared Dec 17, 1997
IL TEST UREA NITROGEN
K974337 · CDQ
Instrumentation Laboratory CO
Chemistry · 29d
Cleared Dec 17, 1997
ELECSYS CK-MB STAT
K974421 · JHY
Boehringer Mannheim Corp.
Chemistry · 23d
Cleared Dec 17, 1997
VIGIL LIPID CONTROL
K974452 · JJY
Beckman Instruments, Inc.
Chemistry · 22d
Cleared Dec 16, 1997
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM DATA DOCK
K972473 · CGA
Lifescan, Inc.
Chemistry · 168d
Cleared Dec 16, 1997
PRESTIGE AQUEOUS GLUCOSE CONTROL LOW, PRESTIGE AQUEOUS GLUCOSE CONTROL HIGH
K973676 · JJX
Sorrento Biochemical, Inc.
Chemistry · 81d
Cleared Dec 15, 1997
ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK...
K973662 · LFR
Boehringer Mannheim Corp.
Chemistry · 81d
Cleared Dec 15, 1997
DIASCAN AQUEOUS GLUCOSE CONTROL LOW, DIASCAN AQUEOUS GLUCOSE CONTROL HIGH
K973677 · JJX
Sorrento Biochemical, Inc.
Chemistry · 80d
Cleared Dec 15, 1997
ULTRA + AQUEOUS GLUCLOSE CONTROL LOW ULTRA + AQUEOUS GLUCOSE CONTROL HIGH
K973678 · JJX
Sorrento Biochemical, Inc.
Chemistry · 80d
Cleared Dec 15, 1997
BECKMAN CALIBRATOR 2 (CAL2)
K973932 · JIX
Beckman Instruments, Inc.
Chemistry · 61d
Cleared Dec 11, 1997
URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)
K970277 · KQP
Astoria-Pacific, Inc.
Chemistry · 322d
Cleared Dec 10, 1997
TRIAGE CARDIAC CONTROLS, TRIAGE TROPONIN-I CONTROL, TRIAGE CK-MB CONTROL,...
K974461 · JJT
Biosite Incorporated
Chemistry · 15d
Cleared Dec 08, 1997
RANDOX BILIRUBIN
K973995 · GIG
Randox Laboratories, Ltd.
Chemistry · 48d
Cleared Dec 08, 1997
AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10
K974053 · JFJ
Diagnostic Chemicals , Ltd.
Chemistry · 42d
Cleared Dec 08, 1997
CHIRON DIAGNOSTICS ACS:180 MYOGLOBIN
K974325 · DDR
Chiron Diagnostics Corp.
Chemistry · 20d
Cleared Dec 08, 1997
ELECSYS CALCHECK VITAMIN B12
K974383 · JJX
Boehringer Mannheim Corp.
Chemistry · 17d
Cleared Dec 08, 1997
ELECSYS CALCHECK FOLATE
K974384 · JJY
Boehringer Mannheim Corp.
Chemistry · 17d
Cleared Dec 05, 1997
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K973616 · MMI
Bayer Corp.
Chemistry · 73d
Cleared Dec 05, 1997
ALANINE AMINOTRANSFERASE-SL ASSAY CATALOGUE NUMBER 318-10, 318-30
K974003 · CKA
Diagnostic Chemicals , Ltd.
Chemistry · 45d
Cleared Dec 05, 1997
ACCUWELL PHENYLALANINE ASSAY
K974047 · JNB
Neometrics, Inc.
Chemistry · 42d
Cleared Dec 03, 1997
SENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM
K973742 · CGZ
Sendx Medical, Inc.
Chemistry · 63d
Cleared Dec 01, 1997
QUICKVUE ONE-STEP HCG-COMBO
K973841 · JHI
Quidel Corp.
Chemistry · 54d
Cleared Dec 01, 1997
BECKMAN URINE PROTEIN CALIBRATOR (UCAL)
K973928 · JIX
Beckman Instruments, Inc.
Chemistry · 47d