FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CHEMCARD GLUCOSE TEST
K Number: K943503
·
Decision Jul 23, 1996
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
9
Review Days
734
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Basic Information
- Device Name
- CHEMCARD GLUCOSE TEST
- K Number
- K943503
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Chem-Elec, Inc.
- Date Received
- July 20, 1994
- Decision Date
- July 23, 1996
- 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 Chem-Elec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K864159 | SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD | Jun 10, 1988 | Substantially Equivalent |
| K811165 | GLUCOSE OXIDASE RATE REAGENT | Aug 13, 1981 | Substantially Equivalent |
| K811406 | CREATININE RATE REAGENT KIT | Aug 13, 1981 | Substantially Equivalent |
| K811381 | ASTRA | Aug 13, 1981 | Substantially Equivalent |
| K811319 | CHLORIDE REAGENT KIT | Aug 13, 1981 | Substantially Equivalent |
| K811193 | BUN RATE REAGENT | Jul 10, 1981 | Substantially Equivalent |
| K811310 | SODIUM/POTASSIUM REAGENT KITS | Jul 10, 1981 | Substantially Equivalent |
| K811701 | CHLORIDE/CARBON DIOXIDE RATE REAGENT | Jul 1, 1981 | Substantially Equivalent |