FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
K Number: K071603
·
Decision Jun 25, 2008
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
27
Applicant Total
343
Review Days
379
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Basic Information
- Device Name
- DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)
- K Number
- K071603
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Behring, Inc.
- Date Received
- June 12, 2007
- Decision Date
- June 25, 2008
- Product Code
- DHX
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DHX | System, Test, Carcinoembryonic Antigen | FDA class 2 | Immunology |
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Other Clearances by Dade Behring, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K093848 | PT-MULTI-CALIBRATOR, MODEL OPAT07 | Dec 20, 2010 | Substantially Equivalent |
| K081161 | DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST | Jul 28, 2008 | Substantially Equivalent |
| K081249 | DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM | Jul 21, 2008 | Substantially Equivalent |
| K071597 | DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 | Jun 4, 2008 | Substantially Equivalent |
| K073604 | DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD | Mar 13, 2008 | Substantially Equivalent |
| K073561 | DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR | Feb 26, 2008 | Substantially Equivalent |
| K073072 | DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B | Feb 21, 2008 | Substantially Equivalent |
| K073055 | DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 | Jan 3, 2008 | Substantially Equivalent |
| K072965 | DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON | Dec 21, 2007 | Substantially Equivalent |
| K072717 | DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210 | Dec 12, 2007 | Substantially Equivalent |