FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)
K Number: K012340
·
Decision Oct 1, 2001
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
45
Applicant Total
96
Review Days
69
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Basic Information
- Device Name
- BAYER ADVIA SYSTEM; UNSATURATED IRON BINDING CAPACITY (UIBC)
- K Number
- K012340
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1415
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bayer Corp.
- Date Received
- July 24, 2001
- Decision Date
- October 1, 2001
- 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
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FDA Class 1
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VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668
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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
DIRECT TIBC KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Bayer Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K024062 | ASCENSIA BREEZE BLOOD GLUCOSE METER | Mar 3, 2003 | Substantially Equivalent |
| K023944 | BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST | Feb 11, 2003 | Substantially Equivalent |
| K024017 | BAYER ADVIA CENTAUR HER-2/NEU ASSAY | Jan 30, 2003 | Substantially Equivalent |
| K024234 | ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL | Jan 23, 2003 | Substantially Equivalent |
| K022288 | COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM | Dec 17, 2002 | Substantially Equivalent |
| K023584 | ASCENSIA DEX 2 DIABETES CARE SYSTEM | Nov 20, 2002 | Substantially Equivalent |
| K020828 | CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM | Jul 24, 2002 | Substantially Equivalent |
| K021428 | CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM | Jul 5, 2002 | Substantially Equivalent |
| K020806 | ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY | Mar 27, 2002 | Substantially Equivalent |
| K013568 | CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Dec 21, 2001 | Substantially Equivalent |