FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BUN RATE REAGENT
K Number: K811193
·
Decision Jul 10, 1981
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
14
Applicant Total
9
Review Days
71
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Basic Information
- Device Name
- BUN RATE REAGENT
- K Number
- K811193
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Chem-Elec, Inc.
- Date Received
- April 30, 1981
- Decision Date
- July 10, 1981
- Product Code
- CDS
- 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 |
|---|---|---|---|
| CDS | Electrode, Ion Specific, Urea Nitrogen | FDA class 2 | Clinical Chemistry |
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epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
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Other Clearances by Chem-Elec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943503 | CHEMCARD GLUCOSE TEST | Jul 23, 1996 | Substantially Equivalent |
| 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 |
| K811310 | SODIUM/POTASSIUM REAGENT KITS | Jul 10, 1981 | Substantially Equivalent |
| K811701 | CHLORIDE/CARBON DIOXIDE RATE REAGENT | Jul 1, 1981 | Substantially Equivalent |