The following data is part of a premarket notification filed by American Dade with the FDA for Smi Multipettor(tm).
Device ID | K863887 |
510k Number | K863887 |
Device Name: | SMI MULTIPETTOR(TM) |
Classification | Station, Pipetting And Diluting, For Clinical Use |
Applicant | AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
Contact | Karen H Darcy |
Correspondent | Karen H Darcy AMERICAN DADE P.O. BOX 25101 Santa Ana, CA 92799 |
Product Code | JQW |
CFR Regulation Number | 862.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-10-06 |
Decision Date | 1986-11-05 |