PYRILINKS-D ASSAY KIT— 510(k) K952320
Substantially EquivalentMetra Biosystems, Inc.
FDA 510(k) clearance K952320 for PYRILINKS-D ASSAY KIT, Substantially Equivalent on 1995-12-29. Applicant: Metra Biosystems, Inc.. Device class: 1.
Clearance details
- Applicant
- Metra Biosystems, Inc.
- Product code
- Code JMM
- Device class
- Class 1
- Regulation
- 21 CFR 862.1400
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Laurel, MD, US
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