The following data is part of a premarket notification filed by New England Nuclear with the FDA for Thyroid Stimulating Hormone.
Device ID | K771590 |
510k Number | K771590 |
Device Name: | THYROID STIMULATING HORMONE |
Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
Applicant | NEW ENGLAND NUCLEAR 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 | 1977-08-19 |
Decision Date | 1977-09-15 |