The following data is part of a premarket notification filed by Proteins Intl., Inc. with the FDA for One Dramshell Vial, Catalog #02-421.
| Device ID | K930382 |
| 510k Number | K930382 |
| Device Name: | ONE DRAMSHELL VIAL, CATALOG #02-421 |
| Classification | Cells, Animal And Human, Cultured |
| Applicant | PROTEINS INTL., INC. 1858 STAR BATT DR. Rochester Hills, MI 48309 |
| Contact | Victoria E Walley |
| Correspondent | Victoria E Walley PROTEINS INTL., INC. 1858 STAR BATT DR. Rochester Hills, MI 48309 |
| Product Code | KIR |
| CFR Regulation Number | 864.2280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-26 |
| Decision Date | 1993-03-23 |