The following data is part of a premarket notification filed by Abbott Diagnostics with the FDA for Abbott Strep A Controls.
| Device ID | K972182 |
| 510k Number | K972182 |
| Device Name: | ABBOTT STREP A CONTROLS |
| Classification | Kit, Direct Antigen, Positive Control |
| Applicant | ABBOTT DIAGNOSTICS 200 ABBOTT PARK RD. DEPT. 9V6, BLDG. AP31 Abbott Park, IL 60064 -3537 |
| Contact | Grace Lemieux |
| Correspondent | Grace Lemieux ABBOTT DIAGNOSTICS 200 ABBOTT PARK RD. DEPT. 9V6, BLDG. AP31 Abbott Park, IL 60064 -3537 |
| Product Code | MJZ |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-29 |
| Decision Date | 1997-08-13 |
| Summary: | summary |