510(k) K760161
K760161 is an FDA 510(k) premarket notification submitted by Princeton Biomedix for the device "TEST, ACID PHOSPHATASE". The FDA issued a decision of Substantially Equivalent on July 20, 1976. The device falls under product code CJR (Acid Phosphatase, Thymol Blue Monophosphate), a Class II device regulated under 21 CFR 862.1020. Princeton Biomedix has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 1976
- Date Received
- July 2, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid Phosphatase, Thymol Blue Monophosphate
- Device Class
- Class II
- Regulation Number
- 862.1020
- Review Panel
- CH
- Submission Type