FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD
K Number: K864159
·
Decision Jun 10, 1988
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
9
Review Days
596
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Basic Information
- Device Name
- SOLID PHASE DETER SERUM CHOLESTEROL FR WHOLE BLOOD
- K Number
- K864159
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Chem-Elec, Inc.
- Date Received
- October 23, 1986
- Decision Date
- June 10, 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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Other Clearances by Chem-Elec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943503 | CHEMCARD GLUCOSE TEST | Jul 23, 1996 | Substantially Equivalent |
| K811165 | GLUCOSE OXIDASE RATE REAGENT | Aug 13, 1981 | Substantially Equivalent |
| K811406 | CREATININE RATE REAGENT KIT | Aug 13, 1981 | Substantially Equivalent |
| K811381 | ASTRA | Aug 13, 1981 | Substantially Equivalent |
| K811319 | CHLORIDE REAGENT KIT | Aug 13, 1981 | Substantially Equivalent |
| K811193 | BUN RATE REAGENT | Jul 10, 1981 | Substantially Equivalent |
| K811310 | SODIUM/POTASSIUM REAGENT KITS | Jul 10, 1981 | Substantially Equivalent |
| K811701 | CHLORIDE/CARBON DIOXIDE RATE REAGENT | Jul 1, 1981 | Substantially Equivalent |