FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBAS REAGENT FOR A-AMYLASE
K Number: K801295
·
Decision Jul 8, 1980
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
98
Applicant Total
11
Review Days
36
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Basic Information
- Device Name
- COBAS REAGENT FOR A-AMYLASE
- K Number
- K801295
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1070
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Roche Analytical Instruments, Inc.
- Date Received
- June 2, 1980
- Decision Date
- July 8, 1980
- Product Code
- JFJ
- 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 |
|---|---|---|---|
| JFJ | Catalytic Methods, Amylase | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
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HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
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ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
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SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
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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 |
| 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 |
| K801117 | COBAS TOTAL BILIRUBIN REAGENT & DILUENT | Jun 9, 1980 | Substantially Equivalent |