FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HDL PRECIPATATING REAGENT SET
K Number: K843894
·
Decision Nov 2, 1984
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
65
Applicant Total
16
Review Days
30
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Basic Information
- Device Name
- HDL PRECIPATATING REAGENT SET
- K Number
- K843894
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Livonia Diagnostics, Inc.
- Date Received
- October 3, 1984
- Decision Date
- November 2, 1984
- Product Code
- LBR
- 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 |
|---|---|---|---|
| LBR | Ldl & Vldl Precipitation, Hdl | 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 |
| 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 |
| 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 |