510(k) K852784
K852784 is an FDA 510(k) premarket notification submitted by Advanced Biomedical Methods, Inc. for the device "ALKALINE PHOSPHATASE". The FDA issued a decision of Substantially Equivalent on July 22, 1985. The device falls under product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Advanced Biomedical Methods, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 1985
- Date Received
- July 1, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Device Class
- Class II
- Regulation Number
- 862.1050
- Review Panel
- CH
- Submission Type