ALKPHASE-B ASSAY KIT
FDA 510(k) clearance K952768 · decided 1995-08-24
Clearance details
- K-number
- K952768
- Device name
- ALKPHASE-B ASSAY KIT
- Applicant
- Metra Biosystems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-06-14
- Decision date
- 1995-08-24
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- CIN
- Device class
- 2
- Regulation number
- 862.1050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Laurel, MD, US
- Third-party review
- No
- Expedited review
- No
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| RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT (K934013) | Isolab, Inc. | 1994-04-26 |
| TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (K930810) | Hybritech, Inc. | 1994-01-11 |
Recalls involving this device
No recalls on record reference this clearance.