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FDA 510(k), K894625, CHLAMYDIA (LGV-1)
FDA 510(k), K894625, CHLAMYDIA (LGV-1)
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510(K) Number: K894625
Device Name: CHLAMYDIA (LGV-1)
Manufacturer: BION ENT., LTD.
Device Classification Name: antisera, fluorescent, chlamydia spp.
Regulation Number: 866.3120
Classification Product Code: LKI
Date Received: 07/20/1989
Decision Date: 08/15/1989
Regulation Medical Specialty: Microbiology
Device Name: CHLAMYDIA (LGV-1)
Manufacturer: BION ENT., LTD.
Device Classification Name: antisera, fluorescent, chlamydia spp.
Regulation Number: 866.3120
Classification Product Code: LKI
Date Received: 07/20/1989
Decision Date: 08/15/1989
Regulation Medical Specialty: Microbiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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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