FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC
K Number: K790556
·
Decision May 7, 1979
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
41
Review Days
49
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Basic Information
- Device Name
- CHOLESTEROL REAGENT, AUTOMATED ENZYMATIC
- K Number
- K790556
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Calbiochem-Behring Corp.
- Date Received
- March 19, 1979
- Decision Date
- May 7, 1979
- 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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| K Number | Device Name | ||
|---|---|---|---|
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| K830214 | AFT SYSTEM III | Mar 9, 1983 | Substantially Equivalent |
| K820812 | CREATINE KINASE-MB KIT | Apr 12, 1982 | Substantially Equivalent |
| K813493 | ENZYGNOST TM RUBELLA IGM | Mar 4, 1982 | Substantially Equivalent |
| K820088 | AFT SYSTEM PROFICIENCY TESTING PROGRAM | Jan 26, 1982 | Substantially Equivalent |
| K812458 | PADAC | Sep 23, 1981 | Substantially Equivalent |
| K810718 | C-PEPTICE REAGENTS | Mar 31, 1981 | Substantially Equivalent |
| K810669 | PANTRAK E.K. | Mar 31, 1981 | Substantially Equivalent |
| K810309 | RUBELLA ANTIBODIES TEST REAGENTS | Mar 11, 1981 | Substantially Equivalent |