FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY
K Number: K980907
·
Decision Oct 16, 1998
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
28
Applicant Total
3
Review Days
220
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Basic Information
- Device Name
- AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY
- K Number
- K980907
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1377
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Axis Biochemicals, Asa
- Date Received
- March 10, 1998
- Decision Date
- October 16, 1998
- Product Code
- LPS
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| LPS | Urinary Homocystine (Nonquantitative) Test System | FDA class 2 | Clinical Chemistry |
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