The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Testpack Plus Strep A With On Board Controls (obc).
| Device ID | K952819 |
| 510k Number | K952819 |
| Device Name: | ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Joanne Rupprecht |
| Correspondent | Joanne Rupprecht ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-20 |
| Decision Date | 1996-01-26 |