FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAGNETIC TIBC KIT
K Number: K990216
·
Decision Feb 16, 1999
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
45
Applicant Total
17
Review Days
25
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Basic Information
- Device Name
- MAGNETIC TIBC KIT
- K Number
- K990216
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1415
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Reference Diagnostics, Inc.
- Date Received
- January 22, 1999
- Decision Date
- February 16, 1999
- 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
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 Reference Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K053211 | RDI HSFERRITIN KIT | Mar 13, 2006 | Substantially Equivalent |
| K053291 | FERRITIN CALIBRATOR SET, CATALOG NO. 8203 | Mar 13, 2006 | Substantially Equivalent |
| K052148 | TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SET | Nov 9, 2005 | Substantially Equivalent |
| K030044 | EXTENDED RANGE HS CRP KIT, CAT NO:9200 | Sep 30, 2003 | Substantially Equivalent |
| K030772 | RDI EXTENDED RANGE CRP CALIBRATOR SET | Apr 11, 2003 | Substantially Equivalent |
| K021609 | RDI HS CRP KIT | Jun 27, 2002 | Substantially Equivalent |
| K021607 | RDI HS CRP CALIBRATOR SET | Jun 27, 2002 | Substantially Equivalent |
| K000783 | DIRECT TIBC CALIBRATOR | May 4, 2000 | Substantially Equivalent |
| K000781 | DIRECT TIBC KIT | May 2, 2000 | Substantially Equivalent |
| K984107 | RDI DIRECT LDL CHOLESTEROL TEST | Jan 28, 1999 | Substantially Equivalent |