FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOTAL BILIRUBIN REAGENT SET
K Number: K910635
·
Decision May 15, 1991
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
234
Applicant Total
20
Review Days
92
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Basic Information
- Device Name
- TOTAL BILIRUBIN REAGENT SET
- K Number
- K910635
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biochemical Trade, Inc.
- Date Received
- February 12, 1991
- Decision Date
- May 15, 1991
- Product Code
- CIG
- 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
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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 |
| K910296 | PHOSPHORUS (INORGANIC) TEST SYSTEM | Feb 27, 1991 | Substantially Equivalent |
| K905776 | ALBUMIN REAGENT SET | Feb 26, 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 |