The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for C-reactive Protein Test Kit.
Device ID | K822332 |
510k Number | K822332 |
Device Name: | C-REACTIVE PROTEIN TEST KIT |
Classification | Calibrator, Primary |
Applicant | SCLAVO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JIS |
CFR Regulation Number | 862.1150 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-04 |
Decision Date | 1982-08-16 |