The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Gibco Mycotect Kit (catalog No. 189-5672).
| Device ID | K860695 |
| 510k Number | K860695 |
| Device Name: | GIBCO MYCOTECT KIT (CATALOG NO. 189-5672) |
| Classification | Kit, Mycoplasma Detection |
| Applicant | GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. P.O. BOX 68 Grandisland, NY 14072 |
| Contact | Gary J Sfeir |
| Correspondent | Gary J Sfeir 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 | 1986-02-25 |
| Decision Date | 1986-03-12 |