510(k) K934584
K934584 is an FDA 510(k) premarket notification submitted by Meditech, Inc. for the device "SPECTROLYSE FACTOR VII:C". The FDA issued a decision of Substantially Equivalent on Dec 6, 1993. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Meditech, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 6, 1993
- Date Received
- Sep 23, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Qualitative And Quantitative Factor Deficiency
- Device Class
- Class II
- Regulation Number
- 864.7290
- Review Panel
- HE
- Submission Type
- 510(k)