The following data is part of a premarket notification filed by Cavro Scientific Instruments, Inc. with the FDA for Mini Sampler Processor.
Device ID | K970616 |
510k Number | K970616 |
Device Name: | MINI SAMPLER PROCESSOR |
Classification | Station, Pipetting And Diluting, For Clinical Use |
Applicant | CAVRO SCIENTIFIC INSTRUMENTS, INC. 242 HUMBOLDT CT. Sunnyvale, CA 94089 |
Contact | Fred Wolcott |
Correspondent | Fred Wolcott CAVRO SCIENTIFIC INSTRUMENTS, INC. 242 HUMBOLDT CT. Sunnyvale, CA 94089 |
Product Code | JQW |
CFR Regulation Number | 862.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-02-18 |
Decision Date | 1997-04-21 |
Summary: | summary |