The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Enzygnost Anti-vzv Igg Test.
| Device ID | K863317 |
| 510k Number | K863317 |
| Device Name: | ENZYGNOST ANTI-VZV IGG TEST |
| Classification | Antiserum, Cf, Varicella-zoster |
| Applicant | BEHRING DIAGNOSTICS, INC. 10933 NO TORREY PINES RD. La Jolla, CA 92037 |
| Contact | John E Hughes |
| Correspondent | John E Hughes BEHRING DIAGNOSTICS, INC. 10933 NO TORREY PINES RD. La Jolla, CA 92037 |
| Product Code | GQX |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-26 |
| Decision Date | 1987-04-22 |