FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SICKLE-HEME A/S CONTROLS & A/A CONTROL
K Number: K831871
·
Decision Jul 28, 1983
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
17
Applicant Total
26
Review Days
45
Basic Information
- Device Name
- SICKLE-HEME A/S CONTROLS & A/A CONTROL
- K Number
- K831871
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7825
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- ANCO MEDICAL REAGENTS & ASSOC.
- Date Received
- June 13, 1983
- Decision Date
- July 28, 1983
- Product Code
- GHM
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| 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.
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Other Clearances by ANCO MEDICAL REAGENTS & ASSOC.
| K Number | Device Name | ||
|---|---|---|---|
| K842440 | SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH | Jul 27, 1984 | Substantially Equivalent |
| K821658 | HEMOGLOBIN REAGENT | Jun 25, 1982 | Substantially Equivalent |
| K821526 | ACID PHOSPHATASE REAGENT SET | Jun 10, 1982 | Substantially Equivalent |
| K821102 | MEGNESIUM REAGENT KIT | May 5, 1982 | Substantially Equivalent |
| K820951 | ENZYMATIC CHOLESTEROL KIT | Apr 26, 1982 | Substantially Equivalent |
| K820491 | SGPT REAGENT SET | Mar 11, 1982 | Substantially Equivalent |
| K820466 | SGOT REAGENT SET | Mar 11, 1982 | Substantially Equivalent |
| K820500 | TOTAL LIPID REAGENT SET | Mar 11, 1982 | Substantially Equivalent |
| K812837 | ALKALINE PHOSPHATASE REAGENT SET | Jan 29, 1982 | Substantially Equivalent |
| K813415 | UREA NITROGEN REAGENT SET | Dec 31, 1981 | Substantially Equivalent |