The following data is part of a premarket notification filed by Intercare Diagnostics, Inc. with the FDA for Indxtm Dip-s-tickstm.
| Device ID | K920569 |
| 510k Number | K920569 |
| Device Name: | INDXTM DIP-S-TICKSTM |
| Classification | Reagent, Rickettsia Serological |
| Applicant | INTERCARE DIAGNOSTICS, INC. P.O. BOX 24124 Baltimore, MD 21227 |
| Contact | Jeffrey Gibbs |
| Correspondent | Jeffrey Gibbs INTERCARE DIAGNOSTICS, INC. P.O. BOX 24124 Baltimore, MD 21227 |
| Product Code | LSQ |
| CFR Regulation Number | 866.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-07 |
| Decision Date | 1993-02-09 |