The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control Low, Medium, High.
Device ID | K063206 |
510k Number | K063206 |
Device Name: | DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH |
Classification | Urinary Homocystine (nonquantitative) Test System |
Applicant | DADE BEHRING, INC. GLASGOW SITE P.O. BOX 6101 Newark, DE 19714 -6101 |
Contact | Kathleen Dray- Lyons |
Correspondent | Kathleen Dray- Lyons DADE BEHRING, INC. GLASGOW SITE P.O. BOX 6101 Newark, DE 19714 -6101 |
Product Code | LPS |
Subsequent Product Code | JIX |
Subsequent Product Code | JJY |
CFR Regulation Number | 862.1377 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-10-23 |
Decision Date | 2006-12-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00842768006128 | K063206 | 000 |