K961370 is an FDA 510(k) clearance for the LA POSITIVE CONTROL PLASMA. This device is classified as a Control, Plasma, Abnormal (Class II - Special Controls, product code GGC).
Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on May 24, 1996, 45 days after receiving the submission on April 9, 1996.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K961370 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 1996 |
| Decision Date | May 24, 1996 |
| Days to Decision | 45 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GGC — Control, Plasma, Abnormal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |