FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MATRIX(TM)-96
K Number: K896202
·
Decision Jan 2, 1990
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
62
Applicant Total
3
Review Days
68
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Basic Information
- Device Name
- MATRIX(TM)-96
- K Number
- K896202
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2320
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Canberra Industries, Inc.
- Date Received
- October 26, 1989
- Decision Date
- January 2, 1990
- Product Code
- JJJ
- 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 |
|---|---|---|---|
| JJJ | Counter (Beta, Gamma) For Clinical Use | FDA class 1 | Clinical Chemistry |
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