The following data is part of a premarket notification filed by Medical Technomics, Ltd. with the FDA for Capillary Blood Collection Tube.
| Device ID | K843608 |
| 510k Number | K843608 |
| Device Name: | CAPILLARY BLOOD COLLECTION TUBE |
| Classification | Tube, Collection, Capillary Blood |
| Applicant | MEDICAL TECHNOMICS, LTD. 274 COTTAGE HILL AVE. Elmhurst, IL 60126 |
| Contact | Dennis A Aldred |
| Correspondent | Dennis A Aldred MEDICAL TECHNOMICS, LTD. 274 COTTAGE HILL AVE. Elmhurst, IL 60126 |
| Product Code | GIO |
| CFR Regulation Number | 864.6150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-13 |
| Decision Date | 1984-11-30 |