510(k) K914167
K914167 is an FDA 510(k) premarket notification submitted by Eastman Kodak Company for the device "CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE". The FDA issued a decision of Substantially Equivalent on March 17, 1992. The device falls under product code CKE (Acid Phosphatase, Thymolphthale Inmonophosphate), a Class II device regulated under 21 CFR 862.1020. Eastman Kodak Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1992
- Date Received
- September 17, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid Phosphatase, Thymolphthale Inmonophosphate
- Device Class
- Class II
- Regulation Number
- 862.1020
- Review Panel
- CH
- Submission Type