FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PHOTOMETER
K Number: K803285
·
Decision Jan 16, 1981
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
2
Review Days
17
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Basic Information
- Device Name
- PHOTOMETER
- K Number
- K803285
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Turner Designs, Inc.
- Date Received
- December 30, 1980
- Decision Date
- January 16, 1981
- 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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Other Clearances by Turner Designs, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K832975 | BACTERUERIA SCREENING PROCEDURE | Nov 14, 1983 | Substantially Equivalent |