Device Classification Name |
enzymatic method, creatinine |
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---|---|---|---|---|
510(k) Number | K001310 | |||
Device Name | VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 | |||
Original Applicant |
|
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Original Contact | marlene a shulman | |||
Regulation Number | 862.1225 | |||
Classification Product Code |
|
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Subsequent Product Code |
|
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Date Received | 04/25/2000 | |||
Decision Date | 05/05/2000 | |||
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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Type | Special | |||
Reviewed by Third Party | No | |||
Combination Product |
No |