FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PBI PLUS HDL PRECIPITATING REAGENT
K Number: K941744
·
Decision Sep 6, 1994
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
65
Applicant Total
3
Review Days
152
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Basic Information
- Device Name
- PBI PLUS HDL PRECIPITATING REAGENT
- K Number
- K941744
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Merchant House Scientific
- Date Received
- April 7, 1994
- Decision Date
- September 6, 1994
- Product Code
- LBR
- 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 |
|---|---|---|---|
| LBR | Ldl & Vldl Precipitation, Hdl | FDA class 1 | Clinical Chemistry |
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