FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALBUMIN REAGENT SET
K Number: K905776
·
Decision Feb 26, 1991
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
17
Applicant Total
20
Review Days
61
Basic Information
- Device Name
- ALBUMIN REAGENT SET
- K Number
- K905776
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1035
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- BIOCHEMICAL TRADE, INC.
- Date Received
- December 27, 1990
- Decision Date
- February 26, 1991
- Product Code
- CJW
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| CJW | Bromcresol Purple Dye-Binding, Albumin | FDA class 2 | Clinical Chemistry |
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Other Clearances by BIOCHEMICAL TRADE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K942958 | CREATINE KINASE MB DETERMINATION (UV) | Nov 21, 1994 | Substantially Equivalent |
| K910635 | TOTAL BILIRUBIN REAGENT SET | May 15, 1991 | Substantially Equivalent |
| K910296 | PHOSPHORUS (INORGANIC) TEST SYSTEM | Feb 27, 1991 | Substantially Equivalent |
| K905790 | TOTAL PROTEIN REAGENT SET | Feb 21, 1991 | Substantially Equivalent |
| K905619 | CREATININE (RATE) REAGENT SET | Feb 13, 1991 | Substantially Equivalent |
| K905650 | KINETIC ALKALINE PHOSPHATASE DETERMINATION | Feb 13, 1991 | Substantially Equivalent |
| K905651 | KINETIC AMYLASE DETERMINATION | Jan 31, 1991 | Substantially Equivalent |
| K905649 | GAMMA-GLUTAMYL TRANSFERASE DETERMINATION | Jan 30, 1991 | Substantially Equivalent |
| K905588 | CREATINE KINASE UV REAGENT SET | Jan 17, 1991 | Substantially Equivalent |
| K871547 | ULTRA-VIOLET BUN REAGENT KIT (RATE) | Jun 22, 1987 | Substantially Equivalent |