FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CHOLESTEROL RAPID SLAT KIT HDL
K Number: K780331
·
Decision Apr 6, 1978
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
10
Review Days
37
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Basic Information
- Device Name
- CHOLESTEROL RAPID SLAT KIT HDL
- K Number
- K780331
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Pierce Chemical Co.
- Date Received
- February 28, 1978
- Decision Date
- April 6, 1978
- 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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Other Clearances by Pierce Chemical Co.
| K Number | Device Name | ||
|---|---|---|---|
| K895661 | GLYCOTEST II GLYHB ASSAY KIT | Dec 7, 1989 | Substantially Equivalent |
| K831837 | CLINOVATIVE II DIAGNOSTIC KIT | Aug 1, 1983 | Substantially Equivalent |
| K821360 | GLYCO-GEL TEST KIT | Jun 2, 1982 | Substantially Equivalent |
| K820279 | GLYCO-GEL TEST KIT | Apr 8, 1982 | Substantially Equivalent |
| K781897 | STAT KIT, MICROPROTEIN | Jan 10, 1979 | Substantially Equivalent |
| K780827 | URIC ACID RAPID STAT KIT | Jun 13, 1978 | Substantially Equivalent |
| K780826 | BILIRUBIN RAPID STAT KIT | May 26, 1978 | Substantially Equivalent |
| K780825 | TRIGLYCERIDE C-37 RAPID STAT KIT | May 26, 1978 | Substantially Equivalent |
| K780512 | AUTO/STAT KIT | May 3, 1978 | Substantially Equivalent |