FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTICHEM ALKALINE PHOSPHATASE (S0903)
K Number: K873761
·
Decision Oct 7, 1987
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
123
Applicant Total
23
Review Days
21
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Basic Information
- Device Name
- MULTICHEM ALKALINE PHOSPHATASE (S0903)
- K Number
- K873761
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Simmler, Inc.
- Date Received
- September 16, 1987
- Decision Date
- October 7, 1987
- Product Code
- CJE
- 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 |
|---|---|---|---|
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | FDA class 2 | Clinical Chemistry |
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Other Clearances by Simmler, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K895745 | SICKLE CELL SOLUBILITY TEST KIT | Nov 29, 1989 | Substantially Equivalent |
| 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 |
| K873697 | MULTICHEM CALCIUM S0910 | Oct 2, 1987 | Substantially Equivalent |