FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COULTER SERUM IRON/UIBC REAGENT
K Number: K902173
·
Decision Jun 12, 1990
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
66
Applicant Total
51
Review Days
29
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Basic Information
- Device Name
- COULTER SERUM IRON/UIBC REAGENT
- K Number
- K902173
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1410
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Coulter Corp.
- Date Received
- May 14, 1990
- Decision Date
- June 12, 1990
- Product Code
- JIY
- 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 |
|---|---|---|---|
| JIY | Photometric Method, Iron (Non-Heme) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
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IRON-PC-SL ASSAY MODEL # 151-10, 151-26
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|---|---|---|---|
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| K984216 | IMMUNO-TROL CONTROL CELLS | Mar 16, 1999 | Substantially Equivalent |
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| K982172 | CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL | Sep 24, 1998 | Substantially Equivalent |
| K973634 | COULTER AC.T DIFF ANALYZER | Oct 29, 1997 | Substantially Equivalent |