FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
K Number: K063608
·
Decision Feb 23, 2007
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
49
Applicant Total
343
Review Days
81
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Basic Information
- Device Name
- DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
- K Number
- K063608
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Behring, Inc.
- Date Received
- December 4, 2006
- Decision Date
- February 23, 2007
- Product Code
- MSJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| MSJ | Apolipoproteins | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MSJ), ordered by most recent decision date.
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IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Dade Behring, Inc.
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|---|---|---|---|
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| 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 |