The following data is part of a premarket notification filed by Reagent Laboratory, Inc. with the FDA for Blood Bank Supplies.
Device ID | BK860034 |
510k Number | BK860034 |
Device Name: | Blood Bank Supplies |
Classification | Supplies, Blood-bank |
Applicant | Reagent Laboratory, Inc. 300 East Ottawa Avenue Louisville, KY 40209 |
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 | 1987-04-08 |
Decision Date | 1987-06-01 |