codes
Device Classification Name |
tubes, vials, systems, serum separators, blood collection |
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510(k) Number | K002456 | |||
Device Name | MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 | |||
Original Applicant |
|
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Original Contact | james haynes | |||
Regulation Number | 862.1675 | |||
Classification Product Code |
|
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Date Received | 08/10/2000 | |||
Decision Date | 11/02/2000 | |||
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 | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |
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Recalls | CDRH Recalls |