The following data is part of a premarket notification filed by Difco Laboratories, Inc. with the FDA for Bacto(r) Strep Group Kit.
| Device ID | K870854 |
| 510k Number | K870854 |
| Device Name: | BACTO(R) STREP GROUP KIT |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | DIFCO LABORATORIES, INC. 1180 ELLSWORTH RD. Ann Arbor, MI 48104 |
| Contact | Walter S Fisher |
| Correspondent | Walter S Fisher DIFCO LABORATORIES, INC. 1180 ELLSWORTH RD. Ann Arbor, MI 48104 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-03 |
| Decision Date | 1987-04-28 |