The following data is part of a premarket notification filed by Ventrex Laboratories, Inc. with the FDA for Ventrescreen Capillary Blood Collection Tube.
Device ID | K873647 |
510k Number | K873647 |
Device Name: | VENTRESCREEN CAPILLARY BLOOD COLLECTION TUBE |
Classification | Tube, Collection, Capillary Blood |
Applicant | VENTREX LABORATORIES, INC. 217 READ ST. P.O. BOX 9731 Portland, ME 04103 |
Contact | James W Champlin |
Correspondent | James W Champlin VENTREX LABORATORIES, INC. 217 READ ST. P.O. BOX 9731 Portland, ME 04103 |
Product Code | GIO |
CFR Regulation Number | 864.6150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-09 |
Decision Date | 1987-10-20 |