The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, And Dimension Vista Syst.
Device ID | K081161 |
510k Number | K081161 |
Device Name: | DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST |
Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
Applicant | DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 Newark, DE 19714 -6101 |
Contact | Helen M Lee |
Correspondent | Helen M Lee DADE BEHRING, INC. 500 GBC DR, MAILSTOP 514 Newark, DE 19714 -6101 |
Product Code | CFN |
Subsequent Product Code | JIX |
Subsequent Product Code | JJY |
CFR Regulation Number | 866.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-04-24 |
Decision Date | 2008-07-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00842768006180 | K081161 | 000 |