The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Aso Quantum, Antistreptolysin O Test.
Device ID | K801177 |
510k Number | K801177 |
Device Name: | ASO QUANTUM, ANTISTREPTOLYSIN O TEST |
Classification | Antistreptolysin - Titer/streptolysin O Reagent |
Applicant | SCLAVO, 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 | 1980-05-16 |
Decision Date | 1980-07-08 |