FDA 510(k)
Substantially Equivalent
🇺🇸 United States
IN VITRO DIAGNOSTIC TEST
K Number: K770467
·
Decision Apr 27, 1977
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
49
Review Days
48
Basic Information
- Device Name
- IN VITRO DIAGNOSTIC TEST
- K Number
- K770467
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- HOFFMANN-LA ROCHE, INC.
- Date Received
- March 10, 1977
- Decision Date
- April 27, 1977
- Advisory Committee
- Unknown
- Review Advisory Committee
- IM
- Third Party
- N
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