The following data is part of a premarket notification filed by Mct Medical, Inc. with the FDA for Cathra Gram Positive Screen.
| Device ID | K874606 |
| 510k Number | K874606 |
| Device Name: | CATHRA GRAM POSITIVE SCREEN |
| Classification | Gram Positive Identification Panel |
| Applicant | MCT MEDICAL, INC. 599 CARDIGAN RD. P.O. BOX 64022 Shoreview, MN 55126 |
| Contact | Ann Weaver |
| Correspondent | Ann Weaver MCT MEDICAL, INC. 599 CARDIGAN RD. P.O. BOX 64022 Shoreview, MN 55126 |
| Product Code | LQL |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-09 |
| Decision Date | 1988-05-06 |