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FDA 510(k)

AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1

K-Number: K944698 · 1995-03-21

ApplicantOrganon Teknika Corp.
Decision Date1995-03-21
Product CodeCFT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 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 1995-03-21 under 510(k) number K944698. The device is classified under product code CFT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1?

AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 is a medical device that received FDA 510(k) clearance on 1995-03-21. The listed applicant is Organon Teknika Corp.. The 510(k) number is K944698.

When did AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 receive FDA 510(k) clearance?

AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 received FDA 510(k) clearance on 1995-03-21, under 510(k) number K944698.

Who is the listed applicant for AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1?

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 PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1?

The FDA product code for AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 is CFT.

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Other records listing Organon Teknika Corp. as applicant

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Related Devices (Code: CFT)

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.

K971921PROLACTIN (PRL) HORMONE MICROPLATE ELISAMonobindK970281VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORSJohnson & Johnson Clinical Diagnostics, Inc.K970188SEALITE SCIENCES, INC. AQUALITE PROLACTINSealite Sciences, Inc.K964748ELECSYS PROLACTIN ASSAYBoehringer Mannheim Corp.K960561DSL ACTIVE PROLACTIN ELISA MODEL 10-4500Diagnostic Systems Laboratories, Inc.K960060DSL ACTIVE PROLACTIN IRMADiagnostic Systems Laboratories, Inc.

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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