The following data is part of a premarket notification filed by Wampole Laboratories with the FDA for Virogen Cmv Antibody Test.
| Device ID | K875101 |
| 510k Number | K875101 |
| Device Name: | VIROGEN CMV ANTIBODY TEST |
| Classification | Dna-reagents, Campylobacter Spp. |
| Applicant | WAMPOLE LABORATORIES P.O. BOX NO. 1 Cranbury, NJ 08512 |
| Contact | Ann Maclearie |
| Correspondent | Ann Maclearie WAMPOLE LABORATORIES P.O. BOX NO. 1 Cranbury, NJ 08512 |
| Product Code | LQO |
| CFR Regulation Number | 866.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-10 |
| Decision Date | 1988-03-01 |