The following data is part of a premarket notification filed by Medical Diagnostic Technologies, Inc. with the FDA for Fibrinogen Assay Kit.
| Device ID | K896052 |
| 510k Number | K896052 |
| Device Name: | FIBRINOGEN ASSAY KIT |
| Classification | System, Fibrinogen Determination |
| 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 | KQJ |
| CFR Regulation Number | 864.7340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-18 |
| Decision Date | 1989-11-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15391521420821 | K896052 | 000 |
| 15391521420814 | K896052 | 000 |