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FDA 510(k)

AURAFLEX TESTOSTERONE CALIBRATOR PACK

K-Number: K951685 · 1995-11-14

ApplicantOrganon Teknika Corp.
Decision Date1995-11-14
Product CodeCDZ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AURAFLEX TESTOSTERONE CALIBRATOR PACK is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1995-11-14 under 510(k) number K951685. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURAFLEX TESTOSTERONE CALIBRATOR PACK?

AURAFLEX TESTOSTERONE CALIBRATOR PACK is a medical device that received FDA 510(k) clearance on 1995-11-14. The listed applicant is Organon Teknika Corp.. The 510(k) number is K951685.

When did AURAFLEX TESTOSTERONE CALIBRATOR PACK receive FDA 510(k) clearance?

AURAFLEX TESTOSTERONE CALIBRATOR PACK received FDA 510(k) clearance on 1995-11-14, under 510(k) number K951685.

Who is the listed applicant for AURAFLEX TESTOSTERONE CALIBRATOR PACK?

The FDA 510(k) record lists Organon Teknika Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AURAFLEX TESTOSTERONE CALIBRATOR PACK?

The FDA product code for AURAFLEX TESTOSTERONE CALIBRATOR PACK is CDZ.

Related Clinical Trials

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Other records listing Organon Teknika Corp. 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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Related Devices (Code: CDZ)

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

View on FDA Database →

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

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