FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
K Number: K014032
·
Decision Feb 8, 2002
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
79
Applicant Total
149
Review Days
64
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Basic Information
- Device Name
- OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
- K Number
- K014032
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Olympus America, Inc.
- Date Received
- December 6, 2001
- Decision Date
- February 8, 2002
- Product Code
- LBS
- 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 |
|---|---|---|---|
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | FDA class 1 | Clinical Chemistry |
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| K063804 | OLYMPUS TRIGLYCERIDE TEST SYSTEM | Mar 23, 2007 | Substantially Equivalent |
| K061499 | OSFERION | Jan 26, 2007 | Substantially Equivalent |
| K062581 | OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM | Nov 29, 2006 | Substantially Equivalent |
| K061575 | OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 | Oct 5, 2006 | Substantially Equivalent |