LIQUID ALKALINE PHOSHATASE REAGENT SET
FDA 510(k) clearance K973588 · decided 1997-10-22
Clearance details
- K-number
- K973588
- Device name
- LIQUID ALKALINE PHOSHATASE REAGENT SET
- Applicant
- Pointe Scientific, Inc.,
- Decision
- Substantially Equivalent
- Date received
- 1997-09-22
- Decision date
- 1997-10-22
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- CJE
- Device class
- 2
- Regulation number
- 862.1050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Lincoln Park, MI, US
- Third-party review
- No
- Expedited review
- No
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