FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SICKLE CELL REAGENT SET
K Number: K842368
·
Decision Jul 20, 1984
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
17
Applicant Total
16
Review Days
35
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Basic Information
- Device Name
- SICKLE CELL REAGENT SET
- K Number
- K842368
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7825
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Livonia Diagnostics, Inc.
- Date Received
- June 15, 1984
- Decision Date
- July 20, 1984
- Product Code
- GHM
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GHM | Test, Sickle Cell | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GHM), ordered by most recent decision date.
SICKLE-CHEX SOLUBILITY KIT
FDA 510(k)
FDA Class 2
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SICKLE-CHEX
FDA 510(k)
FDA Class 2
·Hematology
SAS SICKLE CELL TEST
FDA 510(k)
FDA Class 2
·Hematology
HEMOCARD HEMOGLOBIN S
FDA 510(k)
FDA Class 2
·Hematology
HEMOCARD-AS
FDA 510(k)
FDA Class 2
·Hematology
THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT
FDA 510(k)
FDA Class 2
·Hematology
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 |
| 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 |