FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DIGENE DCR-1 LUMINOMETER
K Number: K940486
·
Decision Apr 18, 1995
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
1
Review Days
440
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Basic Information
- Device Name
- DIGENE DCR-1 LUMINOMETER
- K Number
- K940486
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Digene Diagnostics, Inc.
- Date Received
- February 2, 1994
- Decision Date
- April 18, 1995
- Product Code
- JJQ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- MI
- 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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