The following data is part of a premarket notification filed by Cetus Corp. with the FDA for Progroup (tm) Automated Liquid Handling System.
Device ID | K861580 |
510k Number | K861580 |
Device Name: | PROGROUP (TM) AUTOMATED LIQUID HANDLING SYSTEM |
Classification | Station, Pipetting And Diluting, For Clinical Use |
Applicant | CETUS CORP. 1400 FIFTY-THIRD ST. Emeryville, CA 94608 |
Contact | Wanda Devlaminck |
Correspondent | Wanda Devlaminck CETUS CORP. 1400 FIFTY-THIRD ST. Emeryville, CA 94608 |
Product Code | JQW |
CFR Regulation Number | 862.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-28 |
Decision Date | 1986-06-27 |