The following data is part of a premarket notification filed by Stephens Scientific with the FDA for Supplies, Blood-bank.
Device ID | BK860030 |
510k Number | BK860030 |
Device Name: | Supplies, Blood-Bank |
Classification | Supplies, Blood-bank |
Applicant | Stephens Scientific 7 Astro Place Box 1116 Denville, NJ 07834 |
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 | 1986-08-27 |
Decision Date | 1986-12-16 |