The following data is part of a premarket notification filed by Jay H. Geller with the FDA for Human C5 Rid Kits.
| Device ID | K942326 |
| 510k Number | K942326 |
| Device Name: | HUMAN C5 RID KITS |
| Classification | Complement C5, Antigen, Antiserum, Control |
| 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 | DAY |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-13 |
| Decision Date | 1995-08-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700010603 | K942326 | 000 |