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
4345–4368 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Oct 29, 1997
MATRIX PLUS MULTI-CALIBRATOR KIT
K973345 · JIX
Verichem Laboratories, Inc.
Chemistry · 54d
Cleared Oct 29, 1997
IMMUSURE
K973894 · JJY
Quantimetrix Corp.
Chemistry · 15d
Cleared Oct 27, 1997
HYDRAGEL 7,15,30, CHOL-HDL KIT
K972015 · LBT
Morax
Chemistry · 150d
Cleared Oct 27, 1997
SPIFE
K972274 · CEF
Helena Laboratories
Chemistry · 131d
Cleared Oct 27, 1997
TBD* ONE-STEP OVULATION PREDICTOR TEST
K973310 · CEP
Armkel, LLC
Chemistry · 54d
Cleared Oct 27, 1997
BRAND NAME *1-STEP PREGNANCY
K973352 · LCX
Armkel, LLC
Chemistry · 52d
Cleared Oct 22, 1997
LIQUID ALKALINE PHOSHATASE REAGENT SET
K973588 · CJE
Pointe Scientific, Inc.,
Chemistry · 30d
Cleared Oct 20, 1997
DBEST REAGENT STRIP FOR URINALYSIS
K973142 · JIL
Ameritek, Inc.
Chemistry · 60d
Cleared Oct 20, 1997
FIRST SIGN
K973208 · LCX
Texas Immunology, Inc.
Chemistry · 54d
Cleared Oct 20, 1997
I-STAT SYSTEM
K973292 · CGL
I-Stat Corp.
Chemistry · 48d
Cleared Oct 20, 1997
ACE CARBAMAZEPINE REAGENT/AED CALIBRATORS
K973535 · KLT
Schiapparelli Biosystems, Inc.
Chemistry · 32d
Cleared Oct 20, 1997
TROPONIN (TROP) METHOD
K973650 · MMI
Dade Chemistry Systems, Inc.
Chemistry · 25d
Cleared Oct 20, 1997
CARDIAC TROPONIN-I (TROP) CALIBRATOR
K973668 · JIT
Dade Intl., Inc.
Chemistry · 25d
Cleared Oct 14, 1997
ABC LINEARITY VERIFIERS
K973790 · JJY
Sc Calibrators & Controls, LLC
Chemistry · 8d
Cleared Oct 14, 1997
ABC CALIBRATION VERIFIERS
K973791 · JJY
Sc Calibrators & Controls, LLC
Chemistry · 8d
Cleared Oct 10, 1997
LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET
K973157 · JQB
Pointe Scientific, Inc.,
Chemistry · 49d
Cleared Oct 09, 1997
GLUCOTREND BASIC SYSTEM
K972876 · LFR
Boehringer Mannheim Corp.
Chemistry · 66d
Cleared Oct 09, 1997
MAGO AUTOMATED EIA PROCESSOR
K973177 · JJF
Diamedix Corp.
Chemistry · 45d
Cleared Oct 08, 1997
LIQUID LDH-L REAGENT SET
K973589 · CFJ
Pointe Scientific, Inc.,
Chemistry · 16d
Cleared Oct 06, 1997
ACCUWELL T4-EIA
K972974 · KLI
Neometrics, Inc.
Chemistry · 56d
Cleared Oct 06, 1997
TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN,...
K973126 · JHX
Biosite Incorporated
Chemistry · 47d
Cleared Oct 06, 1997
MYOGLOBIN CONTROL SET
K973358 · JJX
Boehringer Mannheim Corp.
Chemistry · 28d
Cleared Oct 06, 1997
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
K973367 · CHL
Radiometer America, Inc.
Chemistry · 28d
Cleared Oct 01, 1997
ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000...
K972891 · DKZ
Roche Diagnostic Systems, Inc.
Chemistry · 57d