FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
RANDOX MICROALBUMIN
K Number: K002674
·
Decision Oct 5, 2000
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
3
Applicant Total
116
Review Days
38
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Basic Information
- Device Name
- RANDOX MICROALBUMIN
- K Number
- K002674
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5040
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Randox Laboratories, Ltd.
- Date Received
- August 28, 2000
- Decision Date
- October 5, 2000
- Product Code
- DDZ
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| DDZ | Albumin, Fitc, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DDZ), ordered by most recent decision date.
MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H
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FDA Class 2
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FLUORESCEIN CONJUGATED IMMUNOGLOBIN-
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FDA Class 2
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| K123977 | RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR | Nov 21, 2013 | Substantially Equivalent |
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