The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Tsh Microassay.
Device ID | K890579 |
510k Number | K890579 |
Device Name: | TSH MICROASSAY |
Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
Applicant | DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
Contact | Lin, Ph.d. |
Correspondent | Lin, Ph.d. DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami, FL 33127 |
Product Code | JLW |
CFR Regulation Number | 862.1690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-02-06 |
Decision Date | 1989-03-16 |