The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Lyme Igm Elisa Test System.
| Device ID | K900196 |
| 510k Number | K900196 |
| Device Name: | LYME IGM ELISA TEST SYSTEM |
| Classification | Reagent, Borrelia Serological Reagent |
| Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Contact | W Pickering |
| Correspondent | 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 | 1990-01-16 |
| Decision Date | 1990-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239028112 | K900196 | 000 |
| 04048474028119 | K900196 | 000 |