The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Aptt-ea Reagent, An Ellagic Acid Activated Reagent.
| Device ID | K900049 |
| 510k Number | K900049 |
| Device Name: | APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT |
| Classification | Activated Partial Thromboplastin |
| Applicant | MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6020 NICOLLE ST., STE. D Ventura, CA 93003 |
| Contact | Bick, Phd |
| Correspondent | Bick, Phd MEDICAL DIAGNOSTIC TECHNOLOGIES, INC. 6020 NICOLLE ST., STE. D Ventura, CA 93003 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-03 |
| Decision Date | 1990-01-25 |