FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLUCOSE OXIDASE REAGENT SET
K Number: K855194
·
Decision Jan 14, 1986
Classifications
1
FEI Numbers
145
Registration Numbers
145
Same Product Code
399
Applicant Total
21
Review Days
19
Basic Information
- Device Name
- GLUCOSE OXIDASE REAGENT SET
- K Number
- K855194
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- TECHNOSTICS INTL.
- Date Received
- December 26, 1985
- Decision Date
- January 14, 1986
- 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 TECHNOSTICS INTL.
| K Number | Device Name | ||
|---|---|---|---|
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| K855190 | MAGNESIUM REAGENT SET | Feb 18, 1986 | Substantially Equivalent |
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| K860109 | ENZYMATIC UREA NITROGEN REAGENT SET | Feb 6, 1986 | Substantially Equivalent |
| K860112 | TOTAL LIPIDS REAGENT SET | Jan 24, 1986 | Substantially Equivalent |
| K855185 | GLUCOSE REAGENT SET | Jan 22, 1986 | Substantially Equivalent |
| K855157 | LACTIC DEHYDROGENASE (VV) REAGENT SET | Jan 21, 1986 | Substantially Equivalent |
| K855186 | GAMMA GLUTAMYL TRANSPEPTIDASE (KINECTIC)REAGENTSET | Jan 14, 1986 | Substantially Equivalent |
| K855193 | CREATININE REAGENT SET | Jan 14, 1986 | Substantially Equivalent |