The following data is part of a premarket notification filed by Separation Science Corporation with the FDA for Supplies, Blood-bank.
Device ID | BK880005 |
510k Number | BK880005 |
Device Name: | Supplies, Blood-Bank |
Classification | Supplies, Blood-bank |
Applicant | Separation Science Corporation 169 Avon Street, P.o. Box 643 Stratford, CT 06497 |
Product Code | KSS |
CFR Regulation Number | 864.9050 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-04 |
Decision Date | 1988-06-09 |