510(k) K963640
K963640 is an FDA 510(k) premarket notification submitted by Olympus America, Inc. for the device "OLYMPUS ACID PHOSPHATASE REAGENT". The FDA issued a decision of Substantially Equivalent on February 18, 1997. The device falls under product code CKB (Acid Phosphatase, Naphthyl Phosphate), a Class II device regulated under 21 CFR 862.1020. Olympus America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 1997
- Date Received
- September 12, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid Phosphatase, Naphthyl Phosphate
- Device Class
- Class II
- Regulation Number
- 862.1020
- Review Panel
- CH
- Submission Type