The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Vista C3 And C4 Flex Reagent Cartridge, Protein 1 Calibrator, Control Low, Medium, High.
Device ID | K061852 |
510k Number | K061852 |
Device Name: | DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH |
Classification | Complement C3, 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 | CZW |
Subsequent Product Code | DBI |
Subsequent Product Code | JIX |
Subsequent Product Code | JJY |
CFR Regulation Number | 866.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-06-30 |
Decision Date | 2006-09-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00842768006067 | K061852 | 000 |
00842768006050 | K061852 | 000 |