The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Lyme Elisa Test System.
| Device ID | K885317 |
| 510k Number | K885317 |
| Device Name: | LYME ELISA TEST SYSTEM |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Contact | Donald R Tourville |
| Correspondent | Donald R Tourville 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 | 1988-12-30 |
| Decision Date | 1989-03-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239028099 | K885317 | 000 |
| 04048474028096 | K885317 | 000 |