FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHOLESTEROL DETERMINATION
K Number: K811760
·
Decision Jul 10, 1981
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
11
Review Days
18
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Basic Information
- Device Name
- CHOLESTEROL DETERMINATION
- K Number
- K811760
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biorent Diagnostic, Inc.
- Date Received
- June 22, 1981
- Decision Date
- July 10, 1981
- 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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Other Clearances by Biorent Diagnostic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K832747 | ALBUMIN REAGENT SET | Oct 14, 1983 | Substantially Equivalent |
| K823060 | HEMOGLOBIN REAGENT | Nov 22, 1982 | Substantially Equivalent |
| K823211 | CK-UV REAGENT | Nov 22, 1982 | Substantially Equivalent |
| K822494 | OPTIMIZED UV-GPT REAGENT SET | Sep 21, 1982 | Substantially Equivalent |
| K822493 | OPTIMIZED UV-GOT REAGENT SET | Sep 21, 1982 | Substantially Equivalent |
| K822492 | OPTIMIZED UV-LDH REAGENT SET | Sep 17, 1982 | Substantially Equivalent |
| K820768 | COLORIMETRIC LDH REAGENT SET | Apr 14, 1982 | Substantially Equivalent |
| K820632 | COLORIMETRIC URIC ACID REAGENT SET | Mar 25, 1982 | Substantially Equivalent |
| K813555 | GLUCOSE ENZYME-COLOR REAGENT SET | Jan 18, 1982 | Substantially Equivalent |
| K813244 | UV URIC ACID DETERMINATION | Dec 8, 1981 | Substantially Equivalent |