The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Spectrolyse Heparin (anti-iia).
| Device ID | K972209 |
| 510k Number | K972209 |
| Device Name: | SPECTROLYSE HEPARIN (ANTI-IIA) |
| Classification | Assay, Heparin |
| 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 | KFF |
| CFR Regulation Number | 864.7525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-11 |
| Decision Date | 1997-08-12 |