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FDA 510(k)

AURAFLEX PROGESTERONE 150TEST PACK

K-Number: K951630 · 1995-05-08

ApplicantOrganon Teknika Corp.
Decision Date1995-05-08
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AURAFLEX PROGESTERONE 150TEST 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 1995-05-08 under 510(k) number K951630. The device is classified under product code JLS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AURAFLEX PROGESTERONE 150TEST PACK?

AURAFLEX PROGESTERONE 150TEST PACK is a medical device that received FDA 510(k) clearance on 1995-05-08. The listed applicant is Organon Teknika Corp.. The 510(k) number is K951630.

When did AURAFLEX PROGESTERONE 150TEST PACK receive FDA 510(k) clearance?

AURAFLEX PROGESTERONE 150TEST PACK received FDA 510(k) clearance on 1995-05-08, under 510(k) number K951630.

Who is the listed applicant for AURAFLEX PROGESTERONE 150TEST 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 PROGESTERONE 150TEST PACK?

The FDA product code for AURAFLEX PROGESTERONE 150TEST PACK is JLS.

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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.

K003104BACT/ALERT CSRK000492MDA D-DIMERK000378BACT/ALERT MB CULTURE BOTTLEK994343BACT/ALERT SVK993423BACT/ALERT SAK993421BACT/ALERT SN

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Related Devices (Code: JLS)

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.

K040923LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVAIbl GmbHK973898PROGESTERONE ELISAKmi Diagnostics, Inc.K972133VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)Johnson & Johnson Clinical Diagnostics, Inc.K971725OPUS PROGESTERONEBehring Diagnostics, Inc.K964841ELECSYS PROGESTERONE ASSAYBoehringer Mannheim Corp.K965084VIDAS PROESTERONE (PRG) (30 409)bioMerieux, Inc.

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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