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FDA 510(k), K971640, LEADCARE BLOOD LEAD TESTING SYSTEM
FDA 510(k), K971640, LEADCARE BLOOD LEAD TESTING SYSTEM
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510(K) Number: K971640
Device Name: LEADCARE BLOOD LEAD TESTING SYSTEM
Manufacturer: JAMES MAYOL
Device Classification Name: Lead, Atomic Absorption
Regulation Number: DOF
Classification Product Code: KXA
Date Received: 05/02/1997
Decision Date: 09/09/1997
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Toxicology
Device Name: LEADCARE BLOOD LEAD TESTING SYSTEM
Manufacturer: JAMES MAYOL
Device Classification Name: Lead, Atomic Absorption
Regulation Number: DOF
Classification Product Code: KXA
Date Received: 05/02/1997
Decision Date: 09/09/1997
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Toxicology
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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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