K781023 is an FDA 510(k) clearance for the ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU. This device is classified as a Alpha-1-b-glycoprotein, Antigen, Antiserum, Control (Class I - General Controls, product code DEX).
Submitted by Icl Scientific (Mchenry, US). The FDA issued a Cleared decision on August 14, 1978, 56 days after receiving the submission on June 19, 1978.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5420.
| 510(k) Number | K781023 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 1978 |
| Decision Date | August 14, 1978 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DEX — Alpha-1-b-glycoprotein, Antigen, Antiserum, Control |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.5420 |