K960438 is an FDA 510(k) clearance for the TINTELIZE PAI-1 KIT. This device is classified as a Test, Qualitative And Quantitative Factor Deficiency (Class II - Special Controls, product code GGP).
Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on June 5, 1996, 126 days after receiving the submission on January 31, 1996.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7290.
| 510(k) Number | K960438 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 1996 |
| Decision Date | June 05, 1996 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | GGP — Test, Qualitative And Quantitative Factor Deficiency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7290 |