GLUTATECT— 510(k) K971888

Substantially Equivalent

Alden Scientific, Inc.

FDA 510(k) clearance K971888 for GLUTATECT, Substantially Equivalent on 1998-01-09. Applicant: Alden Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Alden Scientific, Inc.
Product code: Product code JOJ
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 1997-05-21
Decision date: 1998-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Springfield, MA, US

Download summary PDF View on FDA.gov ↗

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