The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Reagents For Tsh Assay.
Device ID | K881381 |
510k Number | K881381 |
Device Name: | REAGENTS FOR TSH ASSAY |
Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
Applicant | SCLAVO, INC. 1240 ELKO DR. Sunnyvale, CA 94089 |
Contact | Michael Brinkley |
Correspondent | Michael Brinkley SCLAVO, INC. 1240 ELKO DR. Sunnyvale, CA 94089 |
Product Code | JLW |
CFR Regulation Number | 862.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-01 |
Decision Date | 1988-07-21 |