510(k) K950015
K950015 is an FDA 510(k) premarket notification submitted by Jay H. Geller for the device "HUMAN PROTEIN C RID TEST KIT". The FDA issued a decision of Substantially Equivalent on March 6, 1995. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Jay H. Geller has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 1995
- Date Received
- January 3, 1995
- 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