FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BICARBONATE REAGENTS AMRESCO PRODUCT #4326020
K Number: K904007
·
Decision Sep 13, 1990
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
85
Applicant Total
39
Review Days
15
Basic Information
- Device Name
- BICARBONATE REAGENTS AMRESCO PRODUCT #4326020
- K Number
- K904007
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1160
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- AMRESCO, INC.
- Date Received
- August 29, 1990
- Decision Date
- September 13, 1990
- Product Code
- KHS
- 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 |
|---|---|---|---|
| KHS | Enzymatic, Carbon-Dioxide | FDA class 2 | Clinical Chemistry |
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Other Clearances by AMRESCO, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K905618 | GGT REAGENT | Feb 26, 1991 | Substantially Equivalent |
| K904468 | DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176 | Jan 17, 1991 | Substantially Equivalent |
| K905684 | ALKALINE PHOSPHATASE | Dec 28, 1990 | Substantially Equivalent |
| K905544 | MAGNESIUM REAGENT | Dec 27, 1990 | Substantially Equivalent |
| K905284 | HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173 | Dec 11, 1990 | Substantially Equivalent |
| K904004 | AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116 | Dec 11, 1990 | Substantially Equivalent |
| K905096 | GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138 | Nov 28, 1990 | Substantially Equivalent |
| K904381 | DIAZO COLORIMENTRY DIRECT BILIRUBIN | Oct 12, 1990 | Substantially Equivalent |
| K903775 | CREATINE PHOSPHOKINASE | Oct 4, 1990 | Substantially Equivalent |
| K903829 | AST REAGENT | Sep 25, 1990 | Substantially Equivalent |