The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Difco Strep A Latex Test.
| Device ID | K854978 |
| 510k Number | K854978 |
| Device Name: | DIFCO STREP A LATEX TEST |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
| Contact | Robert |
| Correspondent | Robert DIFCO LABORATORIES, INC. P.O. BOX 331058 Detroit, MI 48232 -7058 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-12 |
| Decision Date | 1986-03-18 |