definition
| Device Classification Name |
urease and glutamic dehydrogenase, urea nitrogen |
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|---|---|---|---|---|
| 510(k) Number | K000958 | |||
| Device Name | ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS | |||
| Original Applicant |
|
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| Original Contact | wynn stoking | |||
| Regulation Number | 862.1770 | |||
| Classification Product Code |
|
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| Date Received | 03/24/2000 | |||
| Decision Date | 05/24/2000 | |||
| 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 |