K883002 is an FDA 510(k) clearance for the QM300 PREALBUMIN ANTIBODY PACK. This device is classified as a Prealbumin, Antigen, Antiserum, Control (Class I - General Controls, product code JZJ).
Submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on September 22, 1988, 66 days after receiving the submission on July 18, 1988.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5060.
| 510(k) Number | K883002 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 1988 |
| Decision Date | September 22, 1988 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JZJ — Prealbumin, Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5060 |