The following data is part of a premarket notification filed by Matrix Technologies Corp. with the FDA for Electrapette (r).
Device ID | K910140 |
510k Number | K910140 |
Device Name: | ELECTRAPETTE (R) |
Classification | Station, Pipetting And Diluting, For Clinical Use |
Applicant | MATRIX TECHNOLOGIES CORP. 44 STEDMAN ST. Lowell, MA 01851 |
Contact | Robert Zier |
Correspondent | Robert Zier MATRIX TECHNOLOGIES CORP. 44 STEDMAN ST. Lowell, MA 01851 |
Product Code | JQW |
CFR Regulation Number | 862.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-14 |
Decision Date | 1991-02-04 |