FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHOLESTEROL QVET
K Number: K943027
·
Decision Jan 27, 1995
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
27
Review Days
214
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Basic Information
- Device Name
- CHOLESTEROL QVET
- K Number
- K943027
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Prisma Systems
- Date Received
- June 27, 1994
- Decision Date
- January 27, 1995
- Product Code
- CHH
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | FDA class 1 | Clinical Chemistry |
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Other Clearances by Prisma Systems
| K Number | Device Name | ||
|---|---|---|---|
| K950177 | CK QVET | Mar 3, 1995 | Substantially Equivalent |
| K942964 | LACTATE DEHYDROGENASE QVET | Dec 29, 1994 | Substantially Equivalent |
| K942997 | ALKALINE PHOSPHATASE (ALKP) QVET | Dec 29, 1994 | Substantially Equivalent |
| K943001 | MAGNESIUM QVET | Dec 29, 1994 | Substantially Equivalent |
| K942963 | GLUCOSE QVET | Dec 29, 1994 | Substantially Equivalent |
| K943042 | BUN QVET | Dec 29, 1994 | Substantially Equivalent |
| K944102 | AST QVET | Dec 13, 1994 | Substantially Equivalent |
| K943000 | ALBUMIN QVET | Dec 13, 1994 | Substantially Equivalent |
| K943026 | POTASSIUM QVET | Dec 9, 1994 | Substantially Equivalent |
| K943004 | TOTAL PROTEIN QVET | Dec 9, 1994 | Substantially Equivalent |