FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTICHEM LDH-L REAGENT
K Number: K872010
·
Decision Jun 11, 1987
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
110
Applicant Total
23
Review Days
16
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Basic Information
- Device Name
- MULTICHEM LDH-L REAGENT
- K Number
- K872010
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1440
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Simmler, Inc.
- Date Received
- May 26, 1987
- Decision Date
- June 11, 1987
- Product Code
- CFJ
- 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 |
|---|---|---|---|
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CFJ), ordered by most recent decision date.
ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
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S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
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PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM
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LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
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FDA Class 2
·Clinical Chemistry
LIQUID LDH-L REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LACTATE DEHYDROGENASE (LD)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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 |
| K873761 | MULTICHEM ALKALINE PHOSPHATASE (S0903) | Oct 7, 1987 | Substantially Equivalent |