The following data is part of a premarket notification filed by Allertech, Inc. with the FDA for Sterile Empty Vials.
| Device ID | K875227 |
| 510k Number | K875227 |
| Device Name: | STERILE EMPTY VIALS |
| Classification | System, Delivery, Allergen And Vaccine |
| Applicant | ALLERTECH, INC. 7800 S. ELATI Littleton, CO 80120 |
| Contact | Deborah Mcquade |
| Correspondent | Deborah Mcquade ALLERTECH, INC. 7800 S. ELATI Littleton, CO 80120 |
| Product Code | LDH |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-22 |
| Decision Date | 1988-03-04 |