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 |