The following data is part of a premarket notification filed by Scientific Software & Instrument Co. with the FDA for Eclipse.
Device ID | K821007 |
510k Number | K821007 |
Device Name: | ECLIPSE |
Classification | Station, Pipetting And Diluting, For Clinical Use |
Applicant | SCIENTIFIC SOFTWARE & INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JQW |
CFR Regulation Number | 862.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-04-09 |
Decision Date | 1982-05-03 |