The following data is part of a premarket notification filed by Microtech Medical Systems, Inc. with the FDA for Quadra Titer Micro Plates.
Device ID | K850725 |
510k Number | K850725 |
Device Name: | QUADRA TITER MICRO PLATES |
Classification | Device, General Purpose, Microbiology, Diagnostic |
Applicant | MICROTECH MEDICAL SYSTEMS, INC. 401 LAREDO ST., UNIT 1 Aurora, CO 80011 |
Contact | Jerry G Kilgore |
Correspondent | Jerry G Kilgore MICROTECH MEDICAL SYSTEMS, INC. 401 LAREDO ST., UNIT 1 Aurora, CO 80011 |
Product Code | LIB |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-22 |
Decision Date | 1985-04-30 |