The following data is part of a premarket notification filed by Cavro Scientific Instruments, Inc. with the FDA for Cavro Iq-190 Sample Processor.
Device ID | K822208 |
510k Number | K822208 |
Device Name: | CAVRO IQ-190 SAMPLE PROCESSOR |
Classification | Station, Pipetting And Diluting, For Clinical Use |
Applicant | CAVRO SCIENTIFIC INSTRUMENTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JQW |
CFR Regulation Number | 862.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-07-23 |
Decision Date | 1982-08-27 |