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FDA 510(k)

HYDROXYPROGESTERONE BY RIA 17A

K-Number: K840886 · 1984-04-18

ApplicantRadioassay Systems Laboratories, Inc.
Decision Date1984-04-18
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HYDROXYPROGESTERONE BY RIA 17A is the device name listed in this FDA 510(k) record. The listed applicant is Radioassay Systems Laboratories, Inc.. It received FDA 510(k) clearance on 1984-04-18 under 510(k) number K840886. 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 HYDROXYPROGESTERONE BY RIA 17A?

HYDROXYPROGESTERONE BY RIA 17A is a medical device that received FDA 510(k) clearance on 1984-04-18. The listed applicant is Radioassay Systems Laboratories, Inc.. The 510(k) number is K840886.

When did HYDROXYPROGESTERONE BY RIA 17A receive FDA 510(k) clearance?

HYDROXYPROGESTERONE BY RIA 17A received FDA 510(k) clearance on 1984-04-18, under 510(k) number K840886.

Who is the listed applicant for HYDROXYPROGESTERONE BY RIA 17A?

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

What is the FDA product code for HYDROXYPROGESTERONE BY RIA 17A?

The FDA product code for HYDROXYPROGESTERONE BY RIA 17A is JLS.

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Other records listing Radioassay Systems 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.

K862204RSL (125I) ALDOSTERONE KITK842960ANDROSTENEDIONE BY RIAK831855HATCH KITK802195DEHYDROEPIANDROSTERONE SULFATE KIT RIAK800126RSL (125 L) PROGESTERONE KITK791999(125I) TESTOSTERONE KIT

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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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