FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL
K Number: K911347
·
Decision Jun 10, 1991
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
11
Applicant Total
318
Review Days
75
Basic Information
- Device Name
- LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL
- K Number
- K911347
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7415
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- BIO-RAD
- Date Received
- March 27, 1991
- Decision Date
- June 10, 1991
- Product Code
- JCM
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JCM | Control, Hemoglobin, Abnormal | FDA class 2 | Hematology |
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