The following data is part of a premarket notification filed by Life Technologies Corporation with the FDA for Knockout Sr Medium, Knockout Sr Xenofree Medium Model 10828, 12618.
| Device ID | K100616 |
| 510k Number | K100616 |
| Device Name: | KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 |
| Classification | Media, Culture, Ex Vivo, Tissue And Cell |
| Applicant | LIFE TECHNOLOGIES CORPORATION 3175 STALEY ROAD Grand Island, NY 14072 |
| Contact | Kelli Tanzella |
| Correspondent | Kelli Tanzella LIFE TECHNOLOGIES CORPORATION 3175 STALEY ROAD Grand Island, NY 14072 |
| Product Code | NDS |
| CFR Regulation Number | 876.5885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-04 |
| Decision Date | 2010-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10190302002547 | K100616 | 000 |
| 10190302002530 | K100616 | 000 |
| 10190302001588 | K100616 | 000 |
| 10190302001571 | K100616 | 000 |