The following data is part of a premarket notification filed by Marion Laboratories, Inc. with the FDA for Culturette Brand 10-minute Group A Strep I.d..
| Device ID | K853073 |
| 510k Number | K853073 |
| Device Name: | CULTURETTE BRAND 10-MINUTE GROUP A STREP I.D. |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City, MI 64134 |
| Contact | William H Guinty |
| Correspondent | William H Guinty MARION LABORATORIES, INC. P.O. BOX 9627 Kansas City, MI 64134 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-23 |
| Decision Date | 1985-08-01 |