FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM
K Number: K062581
·
Decision Nov 29, 2006
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
241
Applicant Total
149
Review Days
90
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Basic Information
- Device Name
- OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM
- K Number
- K062581
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1690
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Olympus America, Inc.
- Date Received
- August 31, 2006
- Decision Date
- November 29, 2006
- Product Code
- JLW
- 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 |
|---|---|---|---|
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FDA class 2 | Clinical Chemistry |
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Other Clearances by Olympus America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K073487 | OLYMPUS IGM REAGENT | Feb 11, 2008 | Substantially Equivalent |
| K073490 | OLYMPUS IGG REAGENT | Feb 11, 2008 | Substantially Equivalent |
| K073489 | OLYMPUS IGA REAGENT | Feb 11, 2008 | Substantially Equivalent |
| K062862 | OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 | Apr 6, 2007 | Substantially Equivalent |
| K063804 | OLYMPUS TRIGLYCERIDE TEST SYSTEM | Mar 23, 2007 | Substantially Equivalent |
| K061499 | OSFERION | Jan 26, 2007 | Substantially Equivalent |
| K061575 | OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 | Oct 5, 2006 | Substantially Equivalent |
| K060201 | OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. | Jun 6, 2006 | Substantially Equivalent |