The following data is part of a premarket notification filed by Cambridge Medical Technology with the FDA for Matched Component Set For Radioimmuno-.
Device ID | K843635 |
510k Number | K843635 |
Device Name: | MATCHED COMPONENT SET FOR RADIOIMMUNO- |
Classification | Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) |
Applicant | CAMBRIDGE MEDICAL TECHNOLOGY 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JKC |
CFR Regulation Number | 862.1245 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-09-17 |
Decision Date | 1984-09-28 |