FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENZYMATICS, INC., TOTAL CHOLESTEROL TEST
K Number: K911692
·
Decision Aug 16, 1991
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
228
Applicant Total
3
Review Days
122
Basic Information
- Device Name
- ENZYMATICS, INC., TOTAL CHOLESTEROL TEST
- K Number
- K911692
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- ENZYMATICS C/O BURDITT,BOWLES,RADZIUS & RUBERRY
- Date Received
- April 16, 1991
- Decision Date
- August 16, 1991
- Product Code
- CHH
- 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 |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | FDA class 1 | Clinical Chemistry |
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