The following data is part of a premarket notification filed by Medical Device Consultants, Inc. with the FDA for Additional Hemotec Act Coagulation Cartridges.
| Device ID | K853198 |
| 510k Number | K853198 |
| Device Name: | ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | MEDICAL DEVICE CONSULTANTS, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Contact | William A Morton |
| Correspondent | William A Morton MEDICAL DEVICE CONSULTANTS, INC. 45 WEST ST. SUITE 2 Attleboro, MA 02703 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-30 |
| Decision Date | 1985-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169577484 | K853198 | 000 |
| 20613994531821 | K853198 | 000 |
| 20613994417286 | K853198 | 000 |
| 00763000433833 | K853198 | 000 |