FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO
K Number: K854188
·
Decision Nov 25, 1985
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
104
Applicant Total
36
Review Days
41
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Basic Information
- Device Name
- IN VITRO TEST DETERMINATION OF INORGANIC PHOSPHORO
- K Number
- K854188
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1580
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Clinical Data, Inc.
- Date Received
- October 15, 1985
- Decision Date
- November 25, 1985
- 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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