FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PROTEINMETER
K Number: K863112
·
Decision Dec 10, 1986
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
4
Applicant Total
34
Review Days
119
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Basic Information
- Device Name
- PROTEINMETER
- K Number
- K863112
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1635
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- J. D. Assoc.
- Date Received
- August 13, 1986
- Decision Date
- December 10, 1986
- Product Code
- JGP
- 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 |
|---|---|---|---|
| JGP | Lowry (Colorimetric), Total Protein | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JGP), ordered by most recent decision date.
MICROPROTEIN REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VITROS CHEMISTRY PRODUCTS UPRO SLIDES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HEMATOLOGY DATA MANAGEMENT SYS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MICRO LOWRY PROTEINTEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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 |
| 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 |