FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
A-GENT CK-MB
K Number: K782015
·
Decision Feb 1, 1979
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
26
Applicant Total
883
Review Days
58
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Basic Information
- Device Name
- A-GENT CK-MB
- K Number
- K782015
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- December 5, 1978
- Decision Date
- February 1, 1979
- Product Code
- JHW
- 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 |
|---|---|---|---|
| JHW | U.V. Method, Cpk Isoenzymes | FDA class 2 | Clinical Chemistry |
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