PREG-PHILE B— 510(k) K821676
Substantially EquivalentBio Diagnostic Systems, Inc.
FDA 510(k) clearance K821676 for PREG-PHILE B, Substantially Equivalent on 1982-07-16. Applicant: Bio Diagnostic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio Diagnostic Systems, Inc.
- Product code
- Code JHJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, US
Recent devices under product code JHJ
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