The following data is part of a premarket notification filed by Dynatech Corp. with the FDA for Multi Mash 2000.
Device ID | K854603 |
510k Number | K854603 |
Device Name: | MULTI MASH 2000 |
Classification | Device, General Purpose, Microbiology, Diagnostic |
Applicant | DYNATECH CORP. 900 SLATERS LN. Alexandria, VA 22314 |
Contact | Barry S Lazar |
Correspondent | Barry S Lazar DYNATECH CORP. 900 SLATERS LN. Alexandria, VA 22314 |
Product Code | LIB |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-11-18 |
Decision Date | 1985-12-06 |