FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REAGENT, LACTATE DEHYDROGENASE
K Number: K760476
·
Decision Nov 1, 1976
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
110
Applicant Total
14
Review Days
76
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Basic Information
- Device Name
- REAGENT, LACTATE DEHYDROGENASE
- K Number
- K760476
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1440
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Simmler & Son, Inc.
- Date Received
- August 17, 1976
- Decision Date
- November 1, 1976
- 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
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ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
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LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30
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LACTATE DEHYDROGENASE (LD)
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Other Clearances by Simmler & Son, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K780817 | GLOBIN-TERGE | Jul 27, 1978 | Substantially Equivalent |
| K771903 | LIPASE | Dec 6, 1977 | Substantially Equivalent |
| K771906 | PHOSPHATE | Dec 6, 1977 | Substantially Equivalent |
| K771905 | GLYCEROL SUBSTRATE | Dec 6, 1977 | Substantially Equivalent |
| K771904 | GLYCEROL KINASE | Dec 6, 1977 | Substantially Equivalent |
| K761086 | REAGENTS | Jan 12, 1977 | Substantially Equivalent |
| K760473 | REAGENT, ALBUMIN DETERMINATION | Oct 29, 1976 | Substantially Equivalent |
| K760478 | REAGENT, BUN (UREA NITROGEN) DETERM. | Oct 29, 1976 | Substantially Equivalent |
| K760474 | REAGENT, ALKALINE PHOSPHATASE DETERM. | Oct 29, 1976 | Substantially Equivalent |
| K760480 | REAGENT, TOTAL PROTEIN DETERMINATION | Oct 29, 1976 | Substantially Equivalent |