The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for Pth-ria.
Device ID | K844735 |
510k Number | K844735 |
Device Name: | PTH-RIA |
Classification | Radioimmunoassay, Parathyroid Hormone |
Applicant | SYNCOR INTL. CORP. 12847 ARROYO ST. Sylmar, CA 91342 |
Contact | Eleanor V Chiu |
Correspondent | Eleanor V Chiu SYNCOR INTL. CORP. 12847 ARROYO ST. Sylmar, CA 91342 |
Product Code | CEW |
CFR Regulation Number | 862.1545 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-04 |
Decision Date | 1985-04-29 |