The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Vials, Challenge, Endotoxin.
Device ID | BK910010 |
510k Number | BK910010 |
Device Name: | Vials, Challenge, Endotoxin |
Classification | Vials, Challenge, Endotoxin |
Applicant | WHITTAKER BIOPRODUCTS, INC. 8830 Biggs Ford Road Walkersville, MO 21793 |
Product Code | MTS |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-05-12 |
Decision Date | 1991-08-09 |