The following data is part of a premarket notification filed by Dynatech Corp. with the FDA for Microfluor Reader.
Device ID | K822772 |
510k Number | K822772 |
Device Name: | MICROFLUOR READER |
Classification | Fluorometer, For Clinical Use |
Applicant | DYNATECH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KHO |
CFR Regulation Number | 862.2560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-09-14 |
Decision Date | 1982-10-27 |