The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Testpack (tm) Acute Hep A Control Kit.
| Device ID | K863099 |
| 510k Number | K863099 |
| Device Name: | ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT |
| Classification | Oncometer, Plasma, For Clinical Use |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Contact | Matt Klamrzynski |
| Correspondent | Matt Klamrzynski ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | JJK |
| CFR Regulation Number | 862.2720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-13 |
| Decision Date | 1986-09-16 |