FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)
K Number: K980667
·
Decision Apr 21, 1998
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
164
Review Days
60
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Basic Information
- Device Name
- INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)
- K Number
- K980667
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sigma Diagnostics, Inc.
- Date Received
- February 20, 1998
- Decision Date
- April 21, 1998
- 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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|---|---|---|---|
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| K012410 | INFINITY HBA KIT, MODELS 537-A, 537-B | Oct 26, 2001 | Substantially Equivalent |
| K010652 | SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 | Mar 30, 2001 | Substantially Equivalent |
| K010158 | THROMBOMAX-HS WITH CALCIUM, MODEL T6540 | Mar 22, 2001 | Substantially Equivalent |
| K003267 | SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A | Mar 15, 2001 | Substantially Equivalent |
| K003329 | SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 | Mar 1, 2001 | Substantially Equivalent |