FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLUCOSE OXIDASE RATE REAGENT
K Number: K811165
·
Decision Aug 13, 1981
Classifications
1
FEI Numbers
145
Registration Numbers
145
Same Product Code
399
Applicant Total
9
Review Days
107
Basic Information
- Device Name
- GLUCOSE OXIDASE RATE REAGENT
- K Number
- K811165
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- CHEM-ELEC, INC.
- Date Received
- April 28, 1981
- Decision Date
- August 13, 1981
- 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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| K Number | Device Name | ||
|---|---|---|---|
| K943503 | CHEMCARD GLUCOSE TEST | Jul 23, 1996 | Substantially Equivalent |
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| K811381 | ASTRA | Aug 13, 1981 | Substantially Equivalent |
| K811319 | CHLORIDE REAGENT KIT | Aug 13, 1981 | Substantially Equivalent |
| K811406 | CREATININE RATE REAGENT KIT | Aug 13, 1981 | Substantially Equivalent |
| K811310 | SODIUM/POTASSIUM REAGENT KITS | Jul 10, 1981 | Substantially Equivalent |
| K811193 | BUN RATE REAGENT | Jul 10, 1981 | Substantially Equivalent |
| K811701 | CHLORIDE/CARBON DIOXIDE RATE REAGENT | Jul 1, 1981 | Substantially Equivalent |