FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5
K Number: K874031
·
Decision Nov 25, 1987
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
86
Applicant Total
321
Review Days
54
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Basic Information
- Device Name
- IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5
- K Number
- K874031
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5340
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Diagnostic Products Corp.
- Date Received
- October 2, 1987
- Decision Date
- November 25, 1987
- Product Code
- DBF
- 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 |
|---|---|---|---|
| DBF | Ferritin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
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|---|---|---|---|
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| K022603 | IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER | Aug 21, 2002 | Substantially Equivalent |
| K022118 | IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) | Jul 22, 2002 | Substantially Equivalent |
| K021257 | ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) | Jun 3, 2002 | Substantially Equivalent |
| K021208 | IMMULITE 2000 MIXED ALLERGEN PANELS | May 30, 2002 | Substantially Equivalent |