FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL
K Number: K111999
·
Decision Apr 17, 2012
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
10
Applicant Total
27
Review Days
279
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Basic Information
- Device Name
- HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL
- K Number
- K111999
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6550
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Healgen Scientific,, LLC
- Date Received
- July 13, 2011
- Decision Date
- April 17, 2012
- Product Code
- JIO
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| JIO | Blood, Occult, Colorimetric, In Urine | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIO), ordered by most recent decision date.
UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips
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URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS
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FDA Class 2
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URS-1B (BLOOD TEST)
FDA 510(k)
FDA Class 2
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