FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
HAPTOGLOBIN
K Number: K873866
·
Decision Oct 20, 1987
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
17
Applicant Total
73
Review Days
57
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Basic Information
- Device Name
- HAPTOGLOBIN
- K Number
- K873866
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5460
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Unipath , Ltd.
- Date Received
- August 24, 1987
- Decision Date
- October 20, 1987
- 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
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IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT
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IL TEST(TM) HAPTOGLOBIN (HPT)
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| K042280 | FACT PLUS ONE-STEP PREGNANCY TEST KIT | Sep 10, 2004 | Substantially Equivalent |
| K041404 | CLEARBLUE EASY EASY READ PREGNANCY TEST | Jun 8, 2004 | Substantially Equivalent |
| K040341 | CLEARBLUE EASY EARLIEST RESULTS PREGNANCY TEST | Mar 8, 2004 | Substantially Equivalent |
| K040329 | MODIFICATION TO E.P.T. PREGNANCY TEST | Mar 8, 2004 | Substantially Equivalent |
| K033658 | E.P.T. PREGNANCY TEST | Jan 16, 2004 | Substantially Equivalent |
| K032939 | EPT CERTAINTY PREGNANCY TEST | Oct 20, 2003 | Substantially Equivalent |