K821135 is an FDA 510(k) clearance for the PREALBUMIN ENZYME IMMUNOASSAY. This device is classified as a Prealbumin, Antigen, Antiserum, Control (Class I - General Controls, product code JZJ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 5, 1983, 380 days after receiving the submission on April 20, 1982.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 866.5060.
| 510(k) Number | K821135 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 20, 1982 |
| Decision Date | May 05, 1983 |
| Days to Decision | 380 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JZJ — Prealbumin, Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5060 |