FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TOTAL IRON BINDING CAPACITY (TIBC)
K Number: K880546
·
Decision Mar 24, 1988
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
45
Applicant Total
340
Review Days
44
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Basic Information
- Device Name
- TOTAL IRON BINDING CAPACITY (TIBC)
- K Number
- K880546
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1415
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Boehringer Mannheim Corp.
- Date Received
- February 9, 1988
- Decision Date
- March 24, 1988
- 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
·Clinical Chemistry
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 Boehringer Mannheim Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K984326 | ELECYS IGE ASSAY | Feb 8, 1999 | Substantially Equivalent |
| K983047 | ACCU-CHEK HQ SYSTEM | Feb 5, 1999 | Substantially Equivalent |
| K984419 | ELECSYS IGE CALCHECK | Feb 2, 1999 | Substantially Equivalent |
| K984425 | MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR | Jan 20, 1999 | Substantially Equivalent |
| K984372 | ELECSYS CALCHECK TROPONIN T | Dec 14, 1998 | Substantially Equivalent |
| K984105 | ELECSYS TROPONIN T STAT TEST | Dec 8, 1998 | Substantially Equivalent |
| K983503 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 | Dec 1, 1998 | Substantially Equivalent |
| K983469 | PRECISET SERUM PROTEINS CALIBRATOR | Nov 25, 1998 | Substantially Equivalent |
| K983185 | BOEHRINGER MANNHEIM TINA-QUANT IGE TEST | Nov 12, 1998 | Substantially Equivalent |
| K982949 | ELECSYS PSA, MODEL 2010 | Oct 27, 1998 | Substantially Equivalent |