K862087 is an FDA 510(k) clearance for the SANTEST 1AP. This device is classified as a Alpha-1-acid-glycoprotein, Antigen, Antiserum, Control (Class I - General Controls, product code LKL).
Submitted by Scientific Sales Intl., Inc. (Kalamazoo, US). The FDA issued a Cleared decision on December 3, 1986, 184 days after receiving the submission on June 2, 1986.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5420.
| 510(k) Number | K862087 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 1986 |
| Decision Date | December 03, 1986 |
| Days to Decision | 184 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 |