ALKPHASE-B ASSAY KIT— 510(k) K952768
Substantially EquivalentMetra Biosystems, Inc.
FDA 510(k) clearance K952768 for ALKPHASE-B ASSAY KIT, Substantially Equivalent on 1995-08-24. Applicant: Metra Biosystems, Inc.. Device class: 2.
Clearance details
- Applicant
- Metra Biosystems, Inc.
- Product code
- Code CIN
- Device class
- Class 2
- Regulation
- 21 CFR 862.1050
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Laurel, MD, US
Recent devices under product code CIN
view allMore clearances from Metra Biosystems, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.