The following data is part of a premarket notification filed by Jay H. Geller with the FDA for Human Protein C Rid Test Kit.
| Device ID | K950015 |
| 510k Number | K950015 |
| Device Name: | HUMAN PROTEIN C RID TEST KIT |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | JAY H. GELLER 2425 WEST OLYMPIC BLVD. SUITE 600 Santa Monica, CA 90404 |
| Contact | Jay H Geller |
| Correspondent | Jay H Geller JAY H. GELLER 2425 WEST OLYMPIC BLVD. SUITE 600 Santa Monica, CA 90404 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-03 |
| Decision Date | 1995-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700005807 | K950015 | 000 |