The following data is part of a premarket notification filed by Caltag Medsystems Ltd. with the FDA for Transfix/edta Vacuum Blood Collection Tubes.
| Device ID | K162723 |
| 510k Number | K162723 |
| Device Name: | TransFix/EDTA Vacuum Blood Collection Tubes |
| Classification | Tubes, Vacuum Sample, With Anticoagulant |
| Applicant | Caltag Medsystems Ltd. Whiteleaf Business Centre, 11 Little Balmer Buckingham, GB Mk18 1tf |
| Contact | Daniel Harrison |
| Correspondent | Erika B Ammirati Ammirati Regulatory Consulting 575 Shirlynn Court Los Altos, CA 94022 |
| Product Code | GIM |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-29 |
| Decision Date | 2017-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060531711627 | K162723 | 000 |