FDA 510(k)
Substantially Equivalent
🇦🇺 Australia
LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE
K Number: K864360
·
Decision Feb 6, 1987
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
55
Review Days
95
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Basic Information
- Device Name
- LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE
- K Number
- K864360
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Trace Scientific , Ltd.
- Date Received
- November 3, 1986
- Decision Date
- February 6, 1987
- Advisory Committee
- Unknown
- Review Advisory Committee
- CH
- Third Party
- N
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