The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Zeua Mycoplasma.
Device ID | K944417 |
510k Number | K944417 |
Device Name: | ZEUA MYCOPLASMA |
Classification | Antisera, Fluorescent, All, Mycoplasma Spp. |
Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
Contact | Donald R Tourville |
Correspondent | Donald R Tourville ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
Product Code | GRZ |
CFR Regulation Number | 866.3375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-06 |
Decision Date | 1995-08-01 |