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FDA 510(k), K034057, LACRYTEST
FDA 510(k), K034057, LACRYTEST
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510(K) Number: K034057
Device Name: LACRYTEST
Manufacturer: JOEL LESSER
Device Classification Name: Ige, Antigen, Antiserum, Control
Regulation Number: DGC
Classification Product Code: KXA
Date Received: 12/30/2003
Decision Date: 03/09/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Immunology
Device Name: LACRYTEST
Manufacturer: JOEL LESSER
Device Classification Name: Ige, Antigen, Antiserum, Control
Regulation Number: DGC
Classification Product Code: KXA
Date Received: 12/30/2003
Decision Date: 03/09/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Immunology
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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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