PERIOCHECK TM ENZYME ACTIVITY TEST KIT
FDA premarket approval P870059/S001 · decided 1991-10-16
Approval details
- PMA number
- P870059
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PERIOCHECK TM ENZYME ACTIVITY TEST KIT
- Generic name
- KIT, TEST, IN VITRO PERIODONTAL
- Applicant
- Actech Advanced Clinical Technologies, Inc.
- Date received
- 1991-09-06
- Decision date
- 1991-10-16
- Days to decision
- 40 days
- Decision code
- APPR
- Product code
- MCL
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Norwood,, MA
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