DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR— 510(k) K962629

Substantially Equivalent

Casco Standards

FDA 510(k) clearance K962629 for DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR, Substantially Equivalent on 1996-09-13. Applicant: Casco Standards. Device class: 2.

Clearance details

Applicant
Casco Standards
Product code
Code JIX
Device class
Class 2
Regulation
21 CFR 862.1150
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Yarmouth, ME, US
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