FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
K Number: K994115
·
Decision Jan 28, 2000
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
45
Applicant Total
343
Review Days
53
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Basic Information
- Device Name
- TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE
- K Number
- K994115
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1415
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Behring, Inc.
- Date Received
- December 6, 1999
- Decision Date
- January 28, 2000
- Product Code
- JMO
- 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 |
|---|---|---|---|
| JMO | Ferrozine (Colorimetric) Iron Binding Capacity | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JMO), ordered by most recent decision date.
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT
FDA 510(k)
FDA Class 1
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VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITROS CHEMISTRY PRODUCTS DTIBC REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524
FDA 510(k)
FDA Class 1
·Clinical Chemistry
WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002
FDA 510(k)
FDA Class 1
·Clinical Chemistry
BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)
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 |