FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LDH-L REAGENT SET
K Number: K880842
·
Decision Apr 5, 1988
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
110
Applicant Total
20
Review Days
39
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Basic Information
- Device Name
- LDH-L REAGENT SET
- K Number
- K880842
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1440
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Tech-Neal Scientific, Inc.
- Date Received
- February 26, 1988
- Decision Date
- April 5, 1988
- 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 Tech-Neal Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K882256 | MAGNESIUM REAGENT SET | Aug 8, 1988 | Substantially Equivalent |
| K882459 | DIAZO, COLORIMETRIC BILIRUBIN | Aug 2, 1988 | Substantially Equivalent |
| K881239 | GAMMA GLUTAMYL TRANSFERASE REAGENT SET | May 31, 1988 | Substantially Equivalent |
| K881241 | TOTAL BILIRUBIN REAGENT | May 27, 1988 | Substantially Equivalent |
| K880237 | CHOLESTEROL | Apr 28, 1988 | Substantially Equivalent |
| K881237 | CREATINE KINASE (CK) REAGENT SET | Apr 28, 1988 | Substantially Equivalent |
| K881240 | CHLORIDE REAGENT SET | Apr 28, 1988 | Substantially Equivalent |
| K880277 | URIC ACID REAGENT SET | Apr 18, 1988 | Substantially Equivalent |
| K880845 | CALCIUM REAGENT SET | Apr 5, 1988 | Substantially Equivalent |
| K880844 | ALBUMIN REAGENT SET | Apr 5, 1988 | Substantially Equivalent |