The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Lyme Igg Elisa Test System.
| Device ID | K895292 |
| 510k Number | K895292 |
| Device Name: | LYME IGG ELISA TEST SYSTEM |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Contact | Jerry W Pickering |
| Correspondent | Jerry W Pickering ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Product Code | LSR |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-25 |
| Decision Date | 1989-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239028105 | K895292 | 000 |
| 04048474028102 | K895292 | 000 |