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 |