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FDA 510(k), K000578, SERIM LEUKOCYTE ESTERASE TEST STRIPS
FDA 510(k), K000578, SERIM LEUKOCYTE ESTERASE TEST STRIPS
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510(K) Number: K000578
Device Name: SERIM LEUKOCYTE ESTERASE TEST STRIPS
Manufacturer: SERIM RESEARCH CORP.
Device Classification Name: test, urine leukocyte
Regulation Number: 864.7675
Classification Product Code: LJX
Date Received: 02/22/2000
Decision Date: 05/05/2000
Regulation Medical Specialty: Hematology
Device Name: SERIM LEUKOCYTE ESTERASE TEST STRIPS
Manufacturer: SERIM RESEARCH CORP.
Device Classification Name: test, urine leukocyte
Regulation Number: 864.7675
Classification Product Code: LJX
Date Received: 02/22/2000
Decision Date: 05/05/2000
Regulation Medical Specialty: Hematology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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