FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SERUM IRON/VIBC REAGENT SET
K Number: K852161
·
Decision Jun 10, 1985
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
66
Applicant Total
16
Review Days
21
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Basic Information
- Device Name
- SERUM IRON/VIBC REAGENT SET
- K Number
- K852161
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1410
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Livonia Diagnostics, Inc.
- Date Received
- May 20, 1985
- Decision Date
- June 10, 1985
- Product Code
- JIY
- 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 |
|---|---|---|---|
| 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
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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
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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 Livonia Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K844322 | SGOT REAGENT SET | Nov 27, 1984 | Substantially Equivalent |
| K844283 | SGPT REAGENT SET | Nov 27, 1984 | Substantially Equivalent |
| K844237 | ALKALINE PHOSPHATASE REAGENT SET | Nov 20, 1984 | Substantially Equivalent |
| K844156 | UREA NITROGEN REAGENT SET | Nov 13, 1984 | Substantially Equivalent |
| K844182 | INORGANIC PHOSPHORUS REAGENT SET | Nov 9, 1984 | Substantially Equivalent |
| K843894 | HDL PRECIPATATING REAGENT SET | Nov 2, 1984 | Substantially Equivalent |
| K843893 | MAGNESIUM REAGENT SET | Oct 30, 1984 | Substantially Equivalent |
| K844024 | CREATININE REAGENT SET | Oct 30, 1984 | Substantially Equivalent |
| K843895 | TOTAL CALCIUM REAGENT SET | Oct 30, 1984 | Substantially Equivalent |
| K844075 | URIC ACID REAGENT SET | Oct 30, 1984 | Substantially Equivalent |