FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBAS TOTAL BILIRUBIN REAGENT & DILUENT
K Number: K801117
·
Decision Jun 9, 1980
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
234
Applicant Total
11
Review Days
28
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Basic Information
- Device Name
- COBAS TOTAL BILIRUBIN REAGENT & DILUENT
- K Number
- K801117
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Roche Analytical Instruments, Inc.
- Date Received
- May 12, 1980
- Decision Date
- June 9, 1980
- 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 |
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Other Clearances by Roche Analytical Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K801299 | COBAS CK-NAC REAGENT | Jul 14, 1980 | Substantially Equivalent |
| K801298 | COBAS REAGENT FOR TRIGLYCERIDES & COBAS | Jul 8, 1980 | Substantially Equivalent |
| K801295 | COBAS REAGENT FOR A-AMYLASE | Jul 8, 1980 | Substantially Equivalent |
| K801297 | COBAS REAGENT FOR GLUCOSE RAPID | Jun 30, 1980 | Substantially Equivalent |
| K801296 | COBAS REAGENT FOR CHOLESTEROL | Jun 30, 1980 | Substantially Equivalent |
| K801243 | COBAS REAGENTS FOR URIC ACID | Jun 26, 1980 | Substantially Equivalent |
| K801242 | COBAS REAGENT FOR ALKALINE PHOSPHATASE | Jun 20, 1980 | Substantially Equivalent |
| K801118 | COBAS REAGENT FOR AST (SGOT) | Jun 20, 1980 | Substantially Equivalent |
| K801116 | COBAS REAGENT FOR BUN | Jun 17, 1980 | Substantially Equivalent |
| K801119 | COBAS REAGENT FOR ALT (GPT) | Jun 9, 1980 | Substantially Equivalent |