FORMASURE TEST REAGENT— 510(k) K905217

Substantially Equivalent

Di-Chem, Inc.

FDA 510(k) clearance K905217 for FORMASURE TEST REAGENT, Substantially Equivalent on 1991-04-09. Applicant: Di-Chem, Inc.. Device class: 2.

Clearance details

Applicant
Di-Chem, Inc.
Product code
Code LIF
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Maple Grove, MN, US
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