The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Double Antibody Tsh I-125 Radioimmuno.
Device ID | K823688 |
510k Number | K823688 |
Device Name: | DOUBLE ANTIBODY TSH I-125 RADIOIMMUNO |
Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
Applicant | CORNING MEDICAL & SCIENTIFIC 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 | 1982-12-07 |
Decision Date | 1983-01-05 |