The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Tintelize Pai-1 Kit.
| Device ID | K960438 |
| 510k Number | K960438 |
| Device Name: | TINTELIZE PAI-1 KIT |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| Applicant | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6025 NICOLLE ST. Ventura, CA 93003 |
| Contact | Michael D Bick |
| Correspondent | Michael D Bick MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6025 NICOLLE ST. Ventura, CA 93003 |
| Product Code | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-31 |
| Decision Date | 1996-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391521420916 | K960438 | 000 |