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FDA 510(k)

PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM

K-Number: K881514 · 1988-06-16

ApplicantHall Laboratories, Inc.
Decision Date1988-06-16
Product CodeBSK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hall Laboratories, Inc.. It received FDA 510(k) clearance on 1988-06-16 under 510(k) number K881514. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM?

PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM is a medical device that received FDA 510(k) clearance on 1988-06-16. The listed applicant is Hall Laboratories, Inc.. The 510(k) number is K881514.

When did PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM receive FDA 510(k) clearance?

PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM received FDA 510(k) clearance on 1988-06-16, under 510(k) number K881514.

Who is the listed applicant for PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM?

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

What is the FDA product code for PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM?

The FDA product code for PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM is BSK.

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Other records listing Hall Laboratories, Inc. as applicant

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.

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Official Source

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