The following data is part of a premarket notification filed by Microtech Medical Systems, Inc. with the FDA for Mic-concept Inoculator.
Device ID | K851020 |
510k Number | K851020 |
Device Name: | MIC-CONCEPT INOCULATOR |
Classification | Device, Microtiter Diluting/dispensing |
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 | JTC |
CFR Regulation Number | 866.2500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-12 |
Decision Date | 1985-03-29 |