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FDA 510(k), K894410, IMMUNODOT LYME TEST
FDA 510(k), K894410, IMMUNODOT LYME TEST
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510(K) Number: K894410
Device Name: IMMUNODOT LYME TEST
Manufacturer: GENERAL BIOMETRICS, INC.
Device Classification Name: reagent, borrelia serological reagent
Regulation Number: 866.3830
Classification Product Code: LSR
Date Received: 07/17/1989
Decision Date: 10/30/1989
Regulation Medical Specialty: Microbiology
Device Name: IMMUNODOT LYME TEST
Manufacturer: GENERAL BIOMETRICS, INC.
Device Classification Name: reagent, borrelia serological reagent
Regulation Number: 866.3830
Classification Product Code: LSR
Date Received: 07/17/1989
Decision Date: 10/30/1989
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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