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FDA 510(k), K061065, FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
FDA 510(k), K061065, FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
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510(K) Number: K061065
Device Name: FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
Manufacturer: TECO DIAGNOSTICS
Device Classification Name: reagent, occult blood
Regulation Number: 864.6550
Classification Product Code: KHE
Date Received: 04/17/2006
Decision Date: 07/14/2006
Regulation Medical Specialty: Hematology
Device Name: FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
Manufacturer: TECO DIAGNOSTICS
Device Classification Name: reagent, occult blood
Regulation Number: 864.6550
Classification Product Code: KHE
Date Received: 04/17/2006
Decision Date: 07/14/2006
Regulation Medical Specialty: Hematology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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