FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
K Number: K091544
·
Decision Sep 9, 2009
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
110
Applicant Total
5
Review Days
105
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Basic Information
- Device Name
- S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
- K Number
- K091544
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1440
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Alfa Wassermann, Inc.
- Date Received
- May 27, 2009
- Decision Date
- September 9, 2009
- Product Code
- CFJ
- 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 |
|---|---|---|---|
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | FDA class 2 | Clinical Chemistry |
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Other Clearances by Alfa Wassermann, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K091413 | S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) | Oct 26, 2009 | Substantially Equivalent |
| K091333 | S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 | Aug 3, 2009 | Substantially Equivalent |
| K080073 | S-TEST CREATININE (CRE) | Jun 30, 2008 | Substantially Equivalent |
| K063306 | ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 | Apr 17, 2007 | Substantially Equivalent |