Device Classification Name |
ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl |
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---|---|---|---|---|
510(k) Number | K021316 | |||
Device Name | ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR | |||
Original Applicant |
|
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Original Contact | barabra pizza | |||
Regulation Number | 862.1475 | |||
Classification Product Code |
|
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Subsequent Product Code |
|
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Date Received | 04/25/2002 | |||
Decision Date | 07/25/2002 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Clinical Chemistry |
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510k Review Panel |
Clinical Chemistry |
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summary |
summary |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |