FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IL TEST(TM) HAPTOGLOBIN (HPT)
K Number: K915829
·
Decision Jul 29, 1992
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
17
Applicant Total
321
Review Days
212
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Basic Information
- Device Name
- IL TEST(TM) HAPTOGLOBIN (HPT)
- K Number
- K915829
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5460
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Instrumentation Laboratory CO
- Date Received
- December 30, 1991
- Decision Date
- July 29, 1992
- Product Code
- DAD
- 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 |
|---|---|---|---|
| DAD | Haptoglobin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DAD), ordered by most recent decision date.
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N-ASSAY TIA MULTI V-NL
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IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT
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N/T PROTEIN CONTROL SY/L, M AND H
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RAICHEM(TM) SPIA(TM) HAPTOGLOBIN REAGENT
FDA 510(k)
FDA Class 2
·Immunology
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