FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHOLESTEROL DETERMINATION
K Number: K871260
·
Decision Apr 13, 1987
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
20
Review Days
13
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Basic Information
- Device Name
- CHOLESTEROL DETERMINATION
- K Number
- K871260
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biochemical Trade, Inc.
- Date Received
- March 31, 1987
- Decision Date
- April 13, 1987
- Product Code
- CHH
- 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 |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | FDA class 1 | Clinical Chemistry |
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|---|---|---|---|
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| K910635 | TOTAL BILIRUBIN REAGENT SET | May 15, 1991 | Substantially Equivalent |
| K910296 | PHOSPHORUS (INORGANIC) TEST SYSTEM | Feb 27, 1991 | Substantially Equivalent |
| K905776 | ALBUMIN REAGENT SET | Feb 26, 1991 | Substantially Equivalent |
| K905790 | TOTAL PROTEIN REAGENT SET | Feb 21, 1991 | Substantially Equivalent |
| K905619 | CREATININE (RATE) REAGENT SET | Feb 13, 1991 | Substantially Equivalent |
| K905650 | KINETIC ALKALINE PHOSPHATASE DETERMINATION | Feb 13, 1991 | Substantially Equivalent |
| K905651 | KINETIC AMYLASE DETERMINATION | Jan 31, 1991 | Substantially Equivalent |
| K905649 | GAMMA-GLUTAMYL TRANSFERASE DETERMINATION | Jan 30, 1991 | Substantially Equivalent |
| K905588 | CREATINE KINASE UV REAGENT SET | Jan 17, 1991 | Substantially Equivalent |