The following data is part of a premarket notification filed by Dynatech Corp. with the FDA for Micro Stix #011-010-5000 & Holder#5100.
Device ID | K823833 |
510k Number | K823833 |
Device Name: | MICRO STIX #011-010-5000 & HOLDER#5100 |
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 | 1982-12-21 |
Decision Date | 1983-03-08 |