The following data is part of a premarket notification filed by Finnigan Corp. with the FDA for Incos 50 Mass Spectrometer.
Device ID | K880418 |
510k Number | K880418 |
Device Name: | INCOS 50 MASS SPECTROMETER |
Classification | Mass Spectrometer, Clinical Use |
Applicant | FINNIGAN CORP. 7 REGENT ST. SUITE 711 Livingston, NJ 07039 |
Contact | Lehrer, Phd |
Correspondent | Lehrer, Phd FINNIGAN CORP. 7 REGENT ST. SUITE 711 Livingston, NJ 07039 |
Product Code | DOP |
CFR Regulation Number | 862.2860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-02-01 |
Decision Date | 1988-05-31 |