ALKPHASE-B ASSAY KIT
FDA 510(k) clearance K981373 · decided 1998-05-27
Clearance details
- K-number
- K981373
- Device name
- ALKPHASE-B ASSAY KIT
- Applicant
- Metra Biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-16
- Decision date
- 1998-05-27
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- CIN
- Device class
- 2
- Regulation number
- 862.1050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.