The following data is part of a premarket notification filed by Matrix Technologies Corp. with the FDA for Impact.
Device ID | K961694 |
510k Number | K961694 |
Device Name: | IMPACT |
Classification | Station, Pipetting And Diluting, For Clinical Use |
Applicant | MATRIX TECHNOLOGIES CORP. 44 STEDMAN ST. Lowell, MA 01851 |
Contact | Mar Hamel |
Correspondent | Mar Hamel 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 | 1996-05-01 |
Decision Date | 1996-06-21 |