FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
(SKD) CHOLESTEROL TEST KIT
K Number: K875131
·
Decision Mar 1, 1988
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
42
Review Days
77
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Basic Information
- Device Name
- (SKD) CHOLESTEROL TEST KIT
- K Number
- K875131
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Smithkline Diagnostics, Inc.
- Date Received
- December 15, 1987
- Decision Date
- March 1, 1988
- 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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| K880499 | HEMOCCULT SENSITIVE TEST | May 23, 1988 | Substantially Equivalent |
| K862849 | HEMOCCULT WIPE TEST | Dec 9, 1986 | Substantially Equivalent |
| K854723 | SKD ELECTROCHEMICAL SYSTEM (ECS) | Mar 5, 1986 | Substantially Equivalent |
| K852841 | RAPID DIRECT STREP A LATEX AGGLUTINATION TEST | Jul 24, 1985 | Substantially Equivalent |
| K821884 | GASTROCCULT TM | Oct 8, 1982 | Substantially Equivalent |
| K821674 | SPINCHEM ACID PHOSPHATASE REAGENT | Jun 22, 1982 | Substantially Equivalent |
| K821184 | SPIN CHEM REAGENTS & STANDARDS | May 24, 1982 | Substantially Equivalent |