FDA 510(k)
Substantially Equivalent
🇺🇸 United States
HDL CHOLESTEROL-E
K Number: K863065
·
Decision Sep 25, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
34
Review Days
44
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Basic Information
- Device Name
- HDL CHOLESTEROL-E
- K Number
- K863065
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- J. D. Assoc.
- Date Received
- August 12, 1986
- Decision Date
- September 25, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- CH
- Third Party
- N
Other Clearances by J. D. Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K863103 | PEG 6,000 | Jan 13, 1987 | Substantially Equivalent |
| K863054 | AST S.C.E. (GOT) | Jan 13, 1987 | Substantially Equivalent |
| K863069 | MAGNESIOMETER | Dec 31, 1986 | Substantially Equivalent |
| K863079 | CREATINKINETIC | Dec 12, 1986 | Substantially Equivalent |
| K863112 | PROTEINMETER | Dec 10, 1986 | Substantially Equivalent |
| K863068 | LDH S.C.E. | Dec 10, 1986 | Substantially Equivalent |
| K863053 | ALT S.C.E. (GPT) | Dec 10, 1986 | Substantially Equivalent |
| K863066 | TRANSFERMETER | Dec 4, 1986 | Substantially Equivalent |
| K863109 | FERROFAST | Nov 24, 1986 | Substantially Equivalent |
| K863102 | GLUCOMETER-E | Nov 24, 1986 | Substantially Equivalent |