The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Testpack Rsv.
| Device ID | K874127 |
| 510k Number | K874127 |
| Device Name: | ABBOTT TESTPACK RSV |
| Classification | Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Jean Frydman |
| Correspondent | Jean Frydman ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | GQG |
| CFR Regulation Number | 866.3480 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-13 |
| Decision Date | 1988-05-06 |