FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S
K Number: K980331
·
Decision Mar 16, 1998
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
201
Applicant Total
16
Review Days
47
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Basic Information
- Device Name
- IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S
- K Number
- K980331
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- More Diagnostics
- Date Received
- January 28, 1998
- Decision Date
- March 16, 1998
- Product Code
- DIF
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| DIF | Drug Mixture Control Materials | FDA class 1 | Clinical Toxicology |
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FDA 510(k)
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