FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
K Number: K991136
·
Decision May 11, 1999
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
52
Applicant Total
149
Review Days
36
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Basic Information
- Device Name
- B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM
- K Number
- K991136
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5630
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Olympus America, Inc.
- Date Received
- April 5, 1999
- Decision Date
- May 11, 1999
- Product Code
- JZG
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JZG | System, Test, Beta-2-Microglobulin Immunological | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JZG), ordered by most recent decision date.
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ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR
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HUMAN BETA-2 MICROGLOBULIN KIT
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DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M
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FDA Class 2
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QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307
FDA 510(k)
FDA Class 2
·Immunology
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| K063804 | OLYMPUS TRIGLYCERIDE TEST SYSTEM | Mar 23, 2007 | Substantially Equivalent |
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| 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 |