ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247
FDA 510(k) clearance K951584 · decided 1995-08-11
Clearance details
- K-number
- K951584
- Device name
- ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247
- Applicant
- Sigma Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-06
- Decision date
- 1995-08-11
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- CJE
- Device class
- 2
- Regulation number
- 862.1050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.