The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension Automated Ldl Cholesterol Flex Reagentcartridge Method, Model Df131.
| Device ID | K020724 |
| 510k Number | K020724 |
| Device Name: | DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131 |
| Classification | System, Test, Low Density, Lipoprotein |
| Applicant | DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG 500, MS 514 P.O.BOX 6101 Newark, DE 19714 -6101 |
| Contact | Richard M Vaught |
| Correspondent | Richard M Vaught DADE BEHRING, INC. GLASGOW BUSINESS COMMUNITY BLDG 500, MS 514 P.O.BOX 6101 Newark, DE 19714 -6101 |
| Product Code | MRR |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-06 |
| Decision Date | 2002-05-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768005350 | K020724 | 000 |