The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Spectrolyse Antithrombin Iii (anti-xa).
| Device ID | K960871 |
| 510k Number | K960871 |
| Device Name: | SPECTROLYSE ANTITHROMBIN III (ANTI-XA) |
| Classification | Antithrombin Iii Quantitation |
| Applicant | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6025 NICOLLE ST. Ventura, CA 93003 |
| Contact | Michael D Bick, Ph.d. |
| Correspondent | Michael D Bick, Ph.d. MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6025 NICOLLE ST. Ventura, CA 93003 |
| Product Code | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-04 |
| Decision Date | 1996-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391521420541 | K960871 | 000 |