The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Gibco Mycotect 189-5670.
| Device ID | K851275 |
| 510k Number | K851275 |
| Device Name: | GIBCO MYCOTECT 189-5670 |
| Classification | Kit, Mycoplasma Detection |
| Applicant | GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. P.O. BOX 68 Grandisland, NY 14072 |
| Contact | Bruce H Nichols |
| Correspondent | Bruce H Nichols GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. P.O. BOX 68 Grandisland, NY 14072 |
| Product Code | KIW |
| CFR Regulation Number | 864.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-01 |
| Decision Date | 1985-06-21 |