The following data is part of a premarket notification filed by Biokit Usa, Inc. with the FDA for As Latex Plus.
Device ID | K842256 |
510k Number | K842256 |
Device Name: | AS LATEX PLUS |
Classification | Antistreptolysin - Titer/streptolysin O Reagent |
Applicant | BIOKIT USA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GTQ |
CFR Regulation Number | 866.3720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-07 |
Decision Date | 1984-06-19 |