Device Classification Name |
multi-analyte controls, all kinds (assayed) |
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---|---|---|---|---|
510(k) Number | K992034 | |||
Device Name | DOCUMENT THYROID CAL*VER | |||
Applicant |
|
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Applicant Contact | karen hickey | |||
Correspondent |
|
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Correspodent Contact | karen hickey | |||
Regulation Number | 862.1660 | |||
Classification Product Code |
|
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Date Received | 06/16/1999 | |||
Decision Date | 07/23/1999 | |||
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 |