The following data is part of a premarket notification filed by Syncor Intl. Corp. with the FDA for Star Hcg Monoclonal Antibody Immunorad.
Device ID | K832796 |
510k Number | K832796 |
Device Name: | STAR HCG MONOCLONAL ANTIBODY IMMUNORAD |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | SYNCOR INTL. CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-18 |
Decision Date | 1984-01-24 |