The following data is part of a premarket notification filed by Dynatech Corp. with the FDA for Microfluor B Plate & Micro Fluor W Plate.
Device ID | K822960 |
510k Number | K822960 |
Device Name: | MICROFLUOR B PLATE & MICRO FLUOR W PLATE |
Classification | Device, General Purpose, Microbiology, Diagnostic |
Applicant | DYNATECH CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LIB |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-05 |
Decision Date | 1982-11-16 |