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FDA 510(k), K041408, POLYMEDCO OC AUTO MICRO 80 FOB TEST
FDA 510(k), K041408, POLYMEDCO OC AUTO MICRO 80 FOB TEST
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510(K) Number: K041408
Device Name: POLYMEDCO OC AUTO MICRO 80 FOB TEST
Manufacturer: POLYMEDCO, INC.
Device Classification Name: Automated Occult Blood Analyzer
Regulation Number: 864.6550
Classification Product Code: OOX
Date Received: 05/27/2004
Decision Date: 10/21/2004
Regulation Medical Specialty: Hematology
Device Name: POLYMEDCO OC AUTO MICRO 80 FOB TEST
Manufacturer: POLYMEDCO, INC.
Device Classification Name: Automated Occult Blood Analyzer
Regulation Number: 864.6550
Classification Product Code: OOX
Date Received: 05/27/2004
Decision Date: 10/21/2004
Regulation Medical Specialty: Hematology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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