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FDA 510(k), K911627, IMMUNODOT BORRELIA (LYME) TEST
FDA 510(k), K911627, IMMUNODOT BORRELIA (LYME) TEST
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510(K) Number: K911627
Device Name: IMMUNODOT BORRELIA (LYME) TEST
Manufacturer: GENERAL BIOMETRICS, INC.
Device Classification Name: reagent, borrelia serological reagent
Regulation Number: 866.3830
Classification Product Code: LSR
Date Received: 04/11/1991
Decision Date: 04/08/1992
Regulation Medical Specialty: Microbiology
Device Name: IMMUNODOT BORRELIA (LYME) TEST
Manufacturer: GENERAL BIOMETRICS, INC.
Device Classification Name: reagent, borrelia serological reagent
Regulation Number: 866.3830
Classification Product Code: LSR
Date Received: 04/11/1991
Decision Date: 04/08/1992
Regulation Medical Specialty: Microbiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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