FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LDH (UV KINETIC)
K Number: K781128
·
Decision Aug 10, 1978
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
110
Applicant Total
23
Review Days
41
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Basic Information
- Device Name
- LDH (UV KINETIC)
- K Number
- K781128
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1440
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Macomb Chemical Co.
- Date Received
- June 30, 1978
- Decision Date
- August 10, 1978
- 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
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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 Macomb Chemical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K830095 | RAPID CHEM ANALYZER II | Jan 28, 1983 | Substantially Equivalent |
| K823720 | SPECTROPHOTOMETER | Jan 7, 1983 | Substantially Equivalent |
| K810958 | GLYCOHEMOGLOBIN | Sep 16, 1981 | Substantially Equivalent |
| K801086 | P-NITROPHENYL PHOSPHATE | May 28, 1980 | Substantially Equivalent |
| K800719 | ENZYMATIC UREA NITROGEN REAGENT SET REVI | May 8, 1980 | Substantially Equivalent |
| K800720 | MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEO | Apr 21, 1980 | Substantially Equivalent |
| K792532 | GLUCOSE (HEXOKINASE) REAGENT SET | Jan 11, 1980 | Substantially Equivalent |
| K792533 | CREATINE PHOSPHOKINASE (CPK) REAGENT SET | Jan 11, 1980 | Substantially Equivalent |
| K791669 | GLUCOSE OXIDASE REAGENT SET | Sep 24, 1979 | Substantially Equivalent |
| K791511 | ENZYMATIC REAGENT SET, 4X250 ML. | Sep 4, 1979 | Substantially Equivalent |