The following data is part of a premarket notification filed by Greene International Corp. with the FDA for Fixed Vol. Dispensers, Adjust Vol-hunpip.
Device ID | K843073 |
510k Number | K843073 |
Device Name: | FIXED VOL. DISPENSERS, ADJUST VOL-HUNPIP |
Classification | Station, Pipetting And Diluting, For Clinical Use |
Applicant | GREENE INTERNATIONAL CORP. 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 | 1984-08-06 |
Decision Date | 1984-08-24 |