FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAMPLE IDENTIFICATION STATION MODEL 38010
K Number: K884269
·
Decision Jan 9, 1989
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
62
Applicant Total
4
Review Days
90
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Basic Information
- Device Name
- SAMPLE IDENTIFICATION STATION MODEL 38010
- K Number
- K884269
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2320
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Icn Micromedic Systems
- Date Received
- October 11, 1988
- Decision Date
- January 9, 1989
- 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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