FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE
K Number: K761153
·
Decision Dec 9, 1976
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
21
Review Days
10
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Basic Information
- Device Name
- GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE
- K Number
- K761153
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Advanced Biomedical Methods, Inc.
- Date Received
- November 29, 1976
- Decision Date
- December 9, 1976
- Product Code
- CGA
- 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |
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Other Clearances by Advanced Biomedical Methods, Inc.
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|---|---|---|---|
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| K852783 | SGOT/ALT REAGENT | Jul 22, 1985 | Substantially Equivalent |
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| K850380 | INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER | Mar 1, 1985 | Substantially Equivalent |
| K850379 | DIRECT BILIRUBIN FOR DEMAND ANALYZER | Mar 1, 1985 | Substantially Equivalent |
| K850378 | LDH REAGENT FOR DEMAND ANALYZER | Mar 1, 1985 | Substantially Equivalent |
| K850381 | MAGNESIUM REAGENT FOR DEMAND ANALYZER | Mar 1, 1985 | Substantially Equivalent |