K952360 is an FDA 510(k) clearance for the CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN. This device is classified as a Myoglobin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDR).
Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on August 14, 1995, 103 days after receiving the submission on May 3, 1995.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5680.
| 510(k) Number | K952360 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 1995 |
| Decision Date | August 14, 1995 |
| Days to Decision | 103 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DDR — Myoglobin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5680 |