The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Follicle Stimulating Hormone Direct Ria.
Device ID | K811905 |
510k Number | K811905 |
Device Name: | FOLLICLE STIMULATING HORMONE DIRECT RIA |
Classification | Radioimmunoassay, Follicle-stimulating Hormone |
Applicant | Immunalysis Corporation 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CGJ |
CFR Regulation Number | 862.1300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-07-01 |
Decision Date | 1981-07-23 |