The following data is part of a premarket notification filed by Simplicity Diagnostics, Inc. with the FDA for Tech Simple Antistreptolysin O Aso Serum Control.
Device ID | K922723 |
510k Number | K922723 |
Device Name: | TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL |
Classification | Antistreptolysin - Titer/streptolysin O Reagent |
Applicant | SIMPLICITY DIAGNOSTICS, INC. P.O. BOX 730 21 N. YORK ROAD Hatboro, PA 19040 |
Contact | Jeffrey Fleishman |
Correspondent | Jeffrey Fleishman SIMPLICITY DIAGNOSTICS, INC. P.O. BOX 730 21 N. YORK ROAD Hatboro, PA 19040 |
Product Code | GTQ |
CFR Regulation Number | 866.3720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-05 |
Decision Date | 1992-09-18 |