GLUTATECT— 510(k) K971888
Substantially EquivalentAlden 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
- Code JOJ
- Device class
- Class 2
- Regulation
- 21 CFR 880.2800
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Springfield, MA, US
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