The following data is part of a premarket notification filed by Marion Health & Safety, Inc. with the FDA for Viral Culturette Hank's Bal. Salt Sol..
| Device ID | K800832 |
| 510k Number | K800832 |
| Device Name: | VIRAL CULTURETTE HANK'S BAL. SALT SOL. |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | MARION HEALTH & SAFETY, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-14 |
| Decision Date | 1980-05-20 |