The following data is part of a premarket notification filed by Haemonetics Corporation with the FDA for Teg 6s Hemostasis System, Teg 6s Citrated: K, Rt, Ff Assay Cartridge.
| Device ID | K183160 |
| 510k Number | K183160 |
| Device Name: | TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | Haemonetics Corporation 400 Wood Road Braintree, MA 02184 |
| Contact | Nancy Bengtson |
| Correspondent | Mark Anzalone Haemonetics Corporation 400 Wood Road Braintree, MA 02184 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-15 |
| Decision Date | 2019-05-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20812747018460 | K183160 | 000 |