FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IRON QVET
K Number: K943029
·
Decision Dec 2, 1994
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
66
Applicant Total
27
Review Days
158
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Basic Information
- Device Name
- IRON QVET
- K Number
- K943029
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1410
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Prisma Systems
- Date Received
- June 27, 1994
- Decision Date
- December 2, 1994
- Product Code
- JIY
- 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 |
|---|---|---|---|
| JIY | Photometric Method, Iron (Non-Heme) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIY), ordered by most recent decision date.
DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SENTINEL IRON LIQUID
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VITALAB IRON REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IRON-PC-SL ASSAY MODEL # 151-10, 151-26
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Prisma Systems
| K Number | Device Name | ||
|---|---|---|---|
| K950177 | CK QVET | Mar 3, 1995 | Substantially Equivalent |
| K943027 | CHOLESTEROL QVET | Jan 27, 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 |