The following data is part of a premarket notification filed by Corning Medical & Scientific with the FDA for Corning Magic Mab Hcg Radioimmunoassay.
Device ID | K854024 |
510k Number | K854024 |
Device Name: | CORNING MAGIC MAB HCG RADIOIMMUNOASSAY |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | CORNING MEDICAL & SCIENTIFIC CORNING GLASS WORKS Medfield, MA 02052 |
Contact | William J Pignato |
Correspondent | William J Pignato CORNING MEDICAL & SCIENTIFIC CORNING GLASS WORKS Medfield, MA 02052 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-30 |
Decision Date | 1985-11-26 |