FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STRATUS CS MYOGLOBIN (MYO) TESTPAK
K Number: K981102
·
Decision Apr 27, 1998
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
45
Applicant Total
343
Review Days
32
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Basic Information
- Device Name
- STRATUS CS MYOGLOBIN (MYO) TESTPAK
- K Number
- K981102
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5680
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Behring, Inc.
- Date Received
- March 26, 1998
- Decision Date
- April 27, 1998
- Product Code
- DDR
- 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 |
|---|---|---|---|
| DDR | Myoglobin, Antigen, Antiserum, Control | FDA class 2 | Immunology |
Similar 510(k) Clearances
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ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS
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