510(k) K831670
K831670 is an FDA 510(k) premarket notification submitted by Ortho Diagnostic Systems, Inc. for the device "ORTHO*PAP-IA ENDOGENOUS ENZYME IMMUNO". The FDA issued a decision of Substantially Equivalent on August 24, 1983. The device falls under product code JFH (Acid Phosphatase (Prostatic), Tartrate Inhibited), a Class II device regulated under 21 CFR 862.1020. Ortho Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 1983
- Date Received
- May 23, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid Phosphatase (Prostatic), Tartrate Inhibited
- Device Class
- Class II
- Regulation Number
- 862.1020
- Review Panel
- CH
- Submission Type