FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REFLOTRON HDL CHOLESTEROL TEST TABS
K Number: K902568
·
Decision Aug 9, 1990
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
65
Applicant Total
340
Review Days
59
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Basic Information
- Device Name
- REFLOTRON HDL CHOLESTEROL TEST TABS
- K Number
- K902568
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Boehringer Mannheim Corp.
- Date Received
- June 11, 1990
- Decision Date
- August 9, 1990
- Product Code
- LBR
- 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 |
|---|---|---|---|
| LBR | Ldl & Vldl Precipitation, Hdl | FDA class 1 | Clinical Chemistry |
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| K983503 | ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 | Dec 1, 1998 | Substantially Equivalent |
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| K982949 | ELECSYS PSA, MODEL 2010 | Oct 27, 1998 | Substantially Equivalent |