FDA 510(k)
Substantially Equivalent
🇺🇸 United States
TEST, MACROGLOBULIN KIT (ALPHA2)
K Number: K760396
·
Decision Aug 26, 1976
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
92
Review Days
20
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Basic Information
- Device Name
- TEST, MACROGLOBULIN KIT (ALPHA2)
- K Number
- K760396
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Kallestad Laboratories, Inc.
- Date Received
- August 6, 1976
- Decision Date
- August 26, 1976
- Advisory Committee
- Unknown
- Review Advisory Committee
- IM
- Third Party
- N
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