FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SICKLE CELL SOLUBILITY TEST KIT
K Number: K895745
·
Decision Nov 29, 1989
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
23
Review Days
64
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Basic Information
- Device Name
- SICKLE CELL SOLUBILITY TEST KIT
- K Number
- K895745
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7825
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Simmler, Inc.
- Date Received
- September 26, 1989
- Decision Date
- November 29, 1989
- Product Code
- JBB
- 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 |
|---|---|---|---|
| JBB | Solubility, Hemoglobin, Abnormal | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JBB), ordered by most recent decision date.
View allOther Clearances by Simmler, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K874903 | MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) | Feb 11, 1988 | Substantially Equivalent |
| K874595 | MULTICHEM (R) MAGNESIUM REAGENT | Jan 21, 1988 | Substantially Equivalent |
| K874820 | MULTICHEM HDL PRECIPITATING REAGENT #S0914 | Jan 7, 1988 | Substantially Equivalent |
| K874812 | MULTICHEM CHLORIDE REAGENT S0933 | Dec 18, 1987 | Substantially Equivalent |
| K874311 | MULTICHEM (R) TOTAL BILIRUBIN | Nov 25, 1987 | Substantially Equivalent |
| K874049 | MULTICHEM ALBUMIN REAGENT S0902 | Oct 29, 1987 | Substantially Equivalent |
| K874038 | MULTICHEM INORGANIC PHOSPHOROUS S0923 | Oct 28, 1987 | Substantially Equivalent |
| K873725 | MULTICHEM CREATININE REAGENT S0917 | Oct 20, 1987 | Substantially Equivalent |
| K873761 | MULTICHEM ALKALINE PHOSPHATASE (S0903) | Oct 7, 1987 | Substantially Equivalent |
| K873697 | MULTICHEM CALCIUM S0910 | Oct 2, 1987 | Substantially Equivalent |