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FDA 510(k), K022774, IQ 200 SYSTEM
FDA 510(k), K022774, IQ 200 SYSTEM
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510(K) Number: K022774
Device Name: IQ 200 SYSTEM
Manufacturer: HARVEY L KASDAN
Device Classification Name: Counter, Urine Particle
Regulation Number: LKM
Classification Product Code: KXA
Date Received: 08/21/2002
Decision Date: 10/21/2002
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Pathology
Device Name: IQ 200 SYSTEM
Manufacturer: HARVEY L KASDAN
Device Classification Name: Counter, Urine Particle
Regulation Number: LKM
Classification Product Code: KXA
Date Received: 08/21/2002
Decision Date: 10/21/2002
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Pathology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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