FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INORGANIC PHOSPHORUS REAGENT SET
K Number: K844182
·
Decision Nov 9, 1984
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
104
Applicant Total
16
Review Days
14
Basic Information
- Device Name
- INORGANIC PHOSPHORUS REAGENT SET
- K Number
- K844182
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1580
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- LIVONIA DIAGNOSTICS, INC.
- Date Received
- October 26, 1984
- Decision Date
- November 9, 1984
- Product Code
- CEO
- 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 |
|---|---|---|---|
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | FDA class 1 | Clinical Chemistry |
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Other Clearances by LIVONIA DIAGNOSTICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K852161 | SERUM IRON/VIBC REAGENT SET | Jun 10, 1985 | Substantially Equivalent |
| K844283 | SGPT REAGENT SET | Nov 27, 1984 | Substantially Equivalent |
| K844322 | SGOT 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 |
| K843894 | HDL PRECIPATATING REAGENT SET | Nov 2, 1984 | Substantially Equivalent |
| K843893 | MAGNESIUM 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 |
| K844024 | CREATININE REAGENT SET | Oct 30, 1984 | Substantially Equivalent |