FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DOCULMENT(R) CHEM VI CALIBRATION VERIF TEST SET
K Number: K931139
·
Decision May 12, 1993
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
38
Review Days
68
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Basic Information
- Device Name
- DOCULMENT(R) CHEM VI CALIBRATION VERIF TEST SET
- K Number
- K931139
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Casco Standards
- Date Received
- March 5, 1993
- Decision Date
- May 12, 1993
- Product Code
- JJY
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
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