The following data is part of a premarket notification filed by Immuno Assay Corp. with the FDA for Tsh (ria) Kit.
Device ID | K820089 |
510k Number | K820089 |
Device Name: | TSH (RIA) KIT |
Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
Applicant | IMMUNO ASSAY CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JLW |
CFR Regulation Number | 862.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-13 |
Decision Date | 1982-01-28 |