The following data is part of a premarket notification filed by Great Lakes Bioscience with the FDA for Glb Varicella-zoster Virus Fluorescent.
| Device ID | K842096 |
| 510k Number | K842096 |
| Device Name: | GLB VARICELLA-ZOSTER VIRUS FLUORESCENT |
| Classification | Antiserum, Cf, Varicella-zoster |
| Applicant | GREAT LAKES BIOSCIENCE P.O. BOX 364 ST. JOSEPH , MI 49085 - |
| Contact | WAYNE E GLEIBER |
| Correspondent | WAYNE E GLEIBER GREAT LAKES BIOSCIENCE P.O. BOX 364 ST. JOSEPH , MI 49085 - |
| Product Code | GQX |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-25 |
| Decision Date | 1985-01-07 |