FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PEG 6,000
K Number: K863103
·
Decision Jan 13, 1987
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
34
Review Days
153
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Basic Information
- Device Name
- PEG 6,000
- K Number
- K863103
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- J. D. Assoc.
- Date Received
- August 13, 1986
- Decision Date
- January 13, 1987
- Product Code
- CHH
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | FDA class 1 | Clinical Chemistry |
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Other Clearances by J. D. Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K863056 | BILIRUBIN TOTAL | Nov 24, 1986 | Substantially Equivalent |