K863099 is an FDA 510(k) clearance for the ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT. This device is classified as a Oncometer, Plasma, For Clinical Use (Class I - General Controls, product code JJK).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 16, 1986, 34 days after receiving the submission on August 13, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 862.2720.
| 510(k) Number | K863099 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 1986 |
| Decision Date | September 16, 1986 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JJK — Oncometer, Plasma, For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2720 |