FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEPHELOMETER, MIC-2000 LASER
K Number: K790103
·
Decision Mar 12, 1979
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
13
Applicant Total
27
Review Days
55
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Basic Information
- Device Name
- NEPHELOMETER, MIC-2000 LASER
- K Number
- K790103
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2700
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Dynatech Corp.
- Date Received
- January 16, 1979
- Decision Date
- March 12, 1979
- Product Code
- JQX
- 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 |
|---|---|---|---|
| JQX | Nephelometer, For Clinical Use | FDA class 1 | Clinical Chemistry |
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