FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VARIANT II B-THALASSEMIA
K Number: K991127
·
Decision Jun 10, 1999
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
12
Applicant Total
319
Review Days
69
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Basic Information
- Device Name
- VARIANT II B-THALASSEMIA
- K Number
- K991127
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 864.7400
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Rad
- Date Received
- April 2, 1999
- Decision Date
- June 10, 1999
- Product Code
- JPD
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JPD | Hemoglobin A2 Quantitation | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JPD), ordered by most recent decision date.
G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE
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VARIANT BETA-THALASSEMIA SHORT PROGRAM
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GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT
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COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL
FDA 510(k)
FDA Class 2
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COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL
FDA 510(k)
FDA Class 2
·Hematology
COLUMNMATE(TM) BETA-THAL CAT. NO. 4515
FDA 510(k)
FDA Class 2
·Hematology
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