The following data is part of a premarket notification filed by Gull Laboratories, Inc. with the FDA for Vzv Igm Test.
| Device ID | K911301 |
| 510k Number | K911301 |
| Device Name: | VZV IGM TEST |
| Classification | Antiserum, Cf, Varicella-zoster |
| Applicant | GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City, UT 84117 |
| Contact | Fred W Rachford |
| Correspondent | Fred W Rachford GULL LABORATORIES, INC. 1011 EAST 4800 SOUTH Salt Lake City, UT 84117 |
| Product Code | GQX |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-25 |
| Decision Date | 1991-07-17 |