FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇪 Ireland
RANDOX INORGANIC PHOSPHOROUS
K Number: K974605
·
Decision Jan 9, 1998
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
104
Applicant Total
116
Review Days
30
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Basic Information
- Device Name
- RANDOX INORGANIC PHOSPHOROUS
- K Number
- K974605
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1580
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- December 10, 1997
- Decision Date
- January 9, 1998
- Product Code
- CEO
- 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 |
|---|---|---|---|
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | FDA class 1 | Clinical Chemistry |
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