FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P
K Number: K972721
·
Decision Aug 6, 1997
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
492
Applicant Total
296
Review Days
16
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Basic Information
- Device Name
- ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P
- K Number
- K972721
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Roche Diagnostic Systems, Inc.
- Date Received
- July 21, 1997
- Decision Date
- August 6, 1997
- Product Code
- JJX
- 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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