FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HICHEM PHOSPHORUS REAGENT KIT
K Number: K981769
·
Decision Jun 29, 1998
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
104
Applicant Total
4
Review Days
41
Basic Information
- Device Name
- HICHEM PHOSPHORUS REAGENT KIT
- K Number
- K981769
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1580
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ELAN PHARMA, INC.
- Date Received
- May 19, 1998
- Decision Date
- June 29, 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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