K981592 is an FDA 510(k) clearance for the ACS:CENTAUR AFP. This device is classified as a Device, General Purpose, Hematology (Class II - Special Controls, product code LOQ).
Submitted by Chiron Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on July 7, 1998, 64 days after receiving the submission on May 4, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010.
| 510(k) Number | K981592 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1998 |
| Decision Date | July 07, 1998 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | LOQ — Device, General Purpose, Hematology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |