The following data is part of a premarket notification filed by Marion Health & Safety, Inc. with the FDA for Strep Culturette.
| Device ID | K792201 |
| 510k Number | K792201 |
| Device Name: | STREP CULTURETTE |
| Classification | Culture Media, Propagating Transport |
| Applicant | MARION HEALTH & SAFETY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSN |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-02 |
| Decision Date | 1979-11-30 |