510(k) K955638
K955638 is an FDA 510(k) premarket notification submitted by Ortho Diagnostic Systems, Inc. for the device "SYNTHAFAX APTT REAGENT". The FDA issued a decision of Substantially Equivalent on April 23, 1996. The device falls under product code GFO (Activated Partial Thromboplastin), a Class II device regulated under 21 CFR 864.7925. Ortho Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 23, 1996
- Date Received
- December 11, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Activated Partial Thromboplastin
- Device Class
- Class II
- Regulation Number
- 864.7925
- Review Panel
- HE
- Submission Type