FDA 510(k)
Substantially Equivalent
🇺🇸 United States
REAGENTS FOR QUANT. ENZYMATIC DETER.-TR.
K Number: K810951
·
Decision Apr 23, 1981
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
5
Review Days
16
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Basic Information
- Device Name
- REAGENTS FOR QUANT. ENZYMATIC DETER.-TR.
- K Number
- K810951
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Mid Tech, Inc.
- Date Received
- April 7, 1981
- Decision Date
- April 23, 1981
- Advisory Committee
- Unknown
- Review Advisory Committee
- CH
- Third Party
- N