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FDA 510(k)

BIOSURE SPECIMEN COLLECTION CONTAINER

K-Number: K873593 · 1987-11-25

ApplicantBiosure, Inc.
Decision Date1987-11-25
Product CodeKDT
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

BIOSURE SPECIMEN COLLECTION CONTAINER is the device name listed in this FDA 510(k) record. The listed applicant is Biosure, Inc.. It received FDA 510(k) clearance on 1987-11-25 under 510(k) number K873593. The device is classified under product code KDT. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSURE SPECIMEN COLLECTION CONTAINER?

BIOSURE SPECIMEN COLLECTION CONTAINER is a medical device that received FDA 510(k) clearance on 1987-11-25. The listed applicant is Biosure, Inc.. The 510(k) number is K873593.

When did BIOSURE SPECIMEN COLLECTION CONTAINER receive FDA 510(k) clearance?

BIOSURE SPECIMEN COLLECTION CONTAINER received FDA 510(k) clearance on 1987-11-25, under 510(k) number K873593.

Who is the listed applicant for BIOSURE SPECIMEN COLLECTION CONTAINER?

The FDA 510(k) record lists Biosure, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOSURE SPECIMEN COLLECTION CONTAINER?

The FDA product code for BIOSURE SPECIMEN COLLECTION CONTAINER is KDT.

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Related Devices (Code: KDT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K862665NOVACYTE-UXsirius Medical, Inc.K834579BIOSPAL 2400SHospal Medical Corp.K834412PRESERV PVA FIXATIVE 15ML-FORMALIN PKPreventive Diagnostics Corp.K833660PRESERV PVA FIXATIVE -MALIN PACKPreventive Diagnostics Corp.K823773PROVIAL II #006-010-0201Dynatech Corp.K822870STOOL-COLLECTION/PRESERVATION KITAmerican Scientific Products

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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