The following data is part of a premarket notification filed by Schiapparelli Biosystems, Inc. with the FDA for Magnesium Reagent.
Device ID | K952426 |
510k Number | K952426 |
Device Name: | MAGNESIUM REAGENT |
Classification | Photometric Method, Magnesium |
Applicant | SCHIAPPARELLI BIOSYSTEMS, INC. 368 PASSAIC AVE. Fairfield, NJ 07004 |
Contact | Robert J Paquet |
Correspondent | Robert J Paquet SCHIAPPARELLI BIOSYSTEMS, INC. 368 PASSAIC AVE. Fairfield, NJ 07004 |
Product Code | JGJ |
CFR Regulation Number | 862.1495 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-24 |
Decision Date | 1995-08-07 |