The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista (tm) Bhcg Flex(r) Reagent Cartridge, And Bhcg Calibrator, Model# K6430,kc632.
Device ID | K063754 |
510k Number | K063754 |
Device Name: | DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632 |
Classification | System, Test, Human Chorionic Gonadotropin |
Applicant | DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 Newark, DE 19714 -6101 |
Contact | Pamela A Jurga |
Correspondent | Pamela A Jurga DADE BEHRING, INC. P.O. BOX 6101 BLDG 500;M.S.514 Newark, DE 19714 -6101 |
Product Code | DHA |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-12-19 |
Decision Date | 2007-02-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00842768016516 | K063754 | 000 |
00842768015540 | K063754 | 000 |