FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUIDEL REFLECTANCE ANALYZER
K Number: K893738
·
Decision Aug 11, 1989
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
93
Review Days
86
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Basic Information
- Device Name
- QUIDEL REFLECTANCE ANALYZER
- K Number
- K893738
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Quidel Corp.
- Date Received
- May 17, 1989
- Decision Date
- August 11, 1989
- 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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