K884217 is an FDA 510(k) clearance for the TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN. This device is classified as a Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control (Class I - General Controls, product code LKL).
Submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on November 4, 1988, 23 days after receiving the submission on October 12, 1988.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5420.
| 510(k) Number | K884217 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 1988 |
| Decision Date | November 04, 1988 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | LKL — Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5420 |