FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOME BLOOD GLUCOSE MONITOR
K Number: K822486
·
Decision Nov 5, 1982
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
14
Review Days
80
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Basic Information
- Device Name
- HOME BLOOD GLUCOSE MONITOR
- K Number
- K822486
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Pharmaquest Corp.
- Date Received
- August 17, 1982
- Decision Date
- November 5, 1982
- Product Code
- CGA
- 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |
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Other Clearances by Pharmaquest Corp.
| K Number | Device Name | ||
|---|---|---|---|
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| 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 |
| 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 |