The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista A1at Flex Reagent Cartridge And Protein 1 Calibrator And Control Medium And High.
Device ID | K063610 |
510k Number | K063610 |
Device Name: | DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH |
Classification | Alpha-1-antitrypsin, Antigen, Antiserum, Control |
Applicant | DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714 |
Contact | Kathleen Dray-lyons |
Correspondent | Kathleen Dray-lyons DADE BEHRING, INC. P.O. BOX 6101 Newark,, DE 19714 |
Product Code | DEM |
Subsequent Product Code | JIX |
Subsequent Product Code | JJY |
CFR Regulation Number | 866.5130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-12-04 |
Decision Date | 2007-01-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00842768005992 | K063610 | 000 |