FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT
K Number: K982121
·
Decision Sep 17, 1998
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
26
Applicant Total
55
Review Days
93
Basic Information
- Device Name
- ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT
- K Number
- K982121
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5090
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- TRACE SCIENTIFIC LTD.
- Date Received
- June 16, 1998
- Decision Date
- September 17, 1998
- Product Code
- DBM
- 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 |
|---|---|---|---|
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | FDA class 2 | Immunology |
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