The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Immophase B Hcg Radioimmunoassay.
Device ID | K820321 |
510k Number | K820321 |
Device Name: | IMMOPHASE B HCG RADIOIMMUNOASSAY |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | CORNING MEDICAL & SCIENTIFIC 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 | 1982-02-05 |
Decision Date | 1982-03-11 |