FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
K Number: K030045
·
Decision Feb 21, 2003
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
25
Applicant Total
149
Review Days
46
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Basic Information
- Device Name
- OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
- K Number
- K030045
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3240
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Olympus America, Inc.
- Date Received
- January 6, 2003
- Decision Date
- February 21, 2003
- Product Code
- DIH
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| DIH | Colorimetry, Cholinesterase | FDA class 1 | Clinical Toxicology |
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| 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 |
| 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 |