FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522
K Number: K901702
·
Decision Apr 25, 1990
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
126
Applicant Total
56
Review Days
13
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Basic Information
- Device Name
- NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522
- K Number
- K901702
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1030
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- American Research Products Co.
- Date Received
- April 12, 1990
- Decision Date
- April 25, 1990
- Product Code
- CKA
- 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 |
|---|---|---|---|
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | FDA class 1 | Clinical Chemistry |
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Other Clearances by American Research Products Co.
| K Number | Device Name | ||
|---|---|---|---|
| K942984 | BUN REAGENT | Mar 1, 1995 | Substantially Equivalent |
| K901527 | BIURET (COLORMETRIC), TOTAL PROTEIN | Jul 19, 1990 | Substantially Equivalent |
| K901960 | IRON REAGENTS PRODUCT CODES 7725 AND 7726 | May 31, 1990 | Substantially Equivalent |
| K901964 | PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463 | May 31, 1990 | Substantially Equivalent |
| K900827 | COLORIMETRIC CHLORIDE PRODUCT #4314125 | May 2, 1990 | Substantially Equivalent |
| K900667 | AMRESCO LDH-L REAGENTS PRODUCTS #7710, 7711 | Apr 19, 1990 | Substantially Equivalent |
| K900666 | AMRESCO CREATININE REAGENTS PRODUCT #7790, 7791 | Apr 19, 1990 | Substantially Equivalent |
| K900571 | AMRESCO PRODUCT NUMBER 7728 (BILIRUBIN DPD) | Apr 16, 1990 | Substantially Equivalent |
| K900977 | AMRESCO INORGANIC PHOSPHORUS PRODUCT #4312500 | Apr 11, 1990 | Substantially Equivalent |
| K900394 | AMRESCO BUN-KINETIC REAGENTS PRODUCTS #7583 | Apr 11, 1990 | Substantially Equivalent |