The following data is part of a premarket notification filed by Flow Laboratories, Inc. with the FDA for Varicella-zoster Fa Labeled Preserum.
| Device ID | K770810 |
| 510k Number | K770810 |
| Device Name: | VARICELLA-ZOSTER FA LABELED PRESERUM |
| Classification | Antiserum, Cf, Varicella-zoster |
| Applicant | FLOW LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GQX |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-05-03 |
| Decision Date | 1977-05-20 |