K870564 is an FDA 510(k) clearance for the SPQ(TM) TEST SYSTEM FOR APOLIPOPROTEIN B. This device is classified as a Apolipoproteins (Class I - General Controls, product code MSJ).
Submitted by Atlantic Antibodies (Scarborough, US). The FDA issued a Cleared decision on March 24, 1987, 42 days after receiving the submission on February 10, 1987.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1475.
| 510(k) Number | K870564 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 1987 |
| Decision Date | March 24, 1987 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | MSJ — Apolipoproteins |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1475 |