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FDA 510(k)

PROGESTERONE DIRECT RIA KIT (125I)

K-Number: K811907 · 1981-07-23

ApplicantImmunalysis Corporation
Decision Date1981-07-23
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROGESTERONE DIRECT RIA KIT (125I) is the device name listed in this FDA 510(k) record. The listed applicant is Immunalysis Corporation. It received FDA 510(k) clearance on 1981-07-23 under 510(k) number K811907. 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 PROGESTERONE DIRECT RIA KIT (125I)?

PROGESTERONE DIRECT RIA KIT (125I) is a medical device that received FDA 510(k) clearance on 1981-07-23. The listed applicant is Immunalysis Corporation. The 510(k) number is K811907.

When did PROGESTERONE DIRECT RIA KIT (125I) receive FDA 510(k) clearance?

PROGESTERONE DIRECT RIA KIT (125I) received FDA 510(k) clearance on 1981-07-23, under 510(k) number K811907.

Who is the listed applicant for PROGESTERONE DIRECT RIA KIT (125I)?

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

What is the FDA product code for PROGESTERONE DIRECT RIA KIT (125I)?

The FDA product code for PROGESTERONE DIRECT RIA KIT (125I) is JLS.

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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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