FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUANTIMETRIX C-CLEAR(TM)
K Number: K931523
·
Decision Jun 25, 1993
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
2
Applicant Total
38
Review Days
91
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Basic Information
- Device Name
- QUANTIMETRIX C-CLEAR(TM)
- K Number
- K931523
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1095
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Quantimetrix Corp.
- Date Received
- March 26, 1993
- Decision Date
- June 25, 1993
- Product Code
- JMA
- 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 |
|---|---|---|---|
| JMA | Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JMA), ordered by most recent decision date.
HELENA BIOSTRIP A
FDA 510(k)
FDA Class 1
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FDA 510(k)
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