FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM
K Number: K945519
·
Decision Nov 3, 1995
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
14
Review Days
359
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Basic Information
- Device Name
- FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM
- K Number
- K945519
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1505
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Pharmaquest Corp.
- Date Received
- November 9, 1994
- Decision Date
- November 3, 1995
- Product Code
- MPG
- 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 |
|---|---|---|---|
| MPG | Urinary Carbohydrate Analysis Kit | FDA class 1 | Clinical Chemistry |
Other Clearances by Pharmaquest Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K833236 | TELEPHONE TRANSMITTER T-10 EEG | Nov 29, 1983 | Substantially Equivalent |
| K833880 | TELEPHONIC RECEIVER R-10 EEG | Nov 29, 1983 | Substantially Equivalent |
| K830705 | MINI LANCET-BLOOD LANCET | Apr 8, 1983 | Substantially Equivalent |
| K822976 | HYPOCOUNT A | Nov 16, 1982 | Substantially Equivalent |
| K822486 | HOME BLOOD GLUCOSE MONITOR | Nov 5, 1982 | Substantially Equivalent |
| K820248 | RODDER VOLUME VENTILATOR | Apr 16, 1982 | Substantially Equivalent |
| K812849 | PTT-200 TELEPHONIC PULMONARY TRANSMITT | Dec 3, 1981 | Substantially Equivalent |
| K812850 | PTT-200 PULMONARY RECEIVER/MICROPROCES | Dec 3, 1981 | Substantially Equivalent |
| K813010 | EEG TELEPHONE TRANSMITTER, MODEL #T-7 | Nov 16, 1981 | Substantially Equivalent |
| K812683 | NEONATE FLEXFLOAT | Oct 13, 1981 | Substantially Equivalent |