The following data is part of a premarket notification filed by Wellcome Diagnostics with the FDA for Streptex Direct A Zl14.
Device ID | K842827 |
510k Number | K842827 |
Device Name: | STREPTEX DIRECT A ZL14 |
Classification | Antisera, All Groups, Streptococcus Spp. |
Applicant | WELLCOME DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GTZ |
CFR Regulation Number | 866.3740 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-20 |
Decision Date | 1984-08-16 |