510(k) K950015

HUMAN PROTEIN C RID TEST KIT by Jay H. Geller — Product Code GGP

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