510(k) K945414
K945414 is an FDA 510(k) premarket notification submitted by Chrono-Log Corp. for the device "RISTOCETIN COFACTOR ASSAY KIT". The FDA issued a decision of Substantially Equivalent on January 11, 1995. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Chrono-Log Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 11, 1995
- Date Received
- November 7, 1994
- 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