The following data is part of a premarket notification filed by Jay H. Geller with the FDA for Mouse Liver Kidney Stomach Diagnostic Test Kit.
| Device ID | K971658 |
| 510k Number | K971658 |
| Device Name: | MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT |
| Classification | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, 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 | DBL |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-14 |
| Decision Date | 1997-05-23 |