FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRASCAN CLINICAL ANALYZER
K Number: K862999
·
Decision Sep 15, 1986
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
3
Review Days
38
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Basic Information
- Device Name
- ULTRASCAN CLINICAL ANALYZER
- K Number
- K862999
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Specialty Medical Industries, Inc.
- Date Received
- August 8, 1986
- Decision Date
- September 15, 1986
- Product Code
- JJQ
- 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
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