FDA 510(k)

RSL (125 L) PROGESTERONE KIT

K-Number: K800126 · 1980-02-13

ApplicantRadioassay Systems Laboratories, Inc.

Decision Date1980-02-13

Product CodeJLS

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

RSL (125 L) PROGESTERONE KIT 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 1980-02-13 under 510(k) number K800126. 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 RSL (125 L) PROGESTERONE KIT?

RSL (125 L) PROGESTERONE KIT is a medical device that received FDA 510(k) clearance on 1980-02-13. The listed applicant is Radioassay Systems Laboratories, Inc.. The 510(k) number is K800126.

When did RSL (125 L) PROGESTERONE KIT receive FDA 510(k) clearance?

RSL (125 L) PROGESTERONE KIT received FDA 510(k) clearance on 1980-02-13, under 510(k) number K800126.

Who is the listed applicant for RSL (125 L) PROGESTERONE KIT?

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 RSL (125 L) PROGESTERONE KIT?

The FDA product code for RSL (125 L) PROGESTERONE KIT is JLS.

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Other records listing Radioassay Systems Laboratories, Inc. as applicant

K862204RSL (125I) ALDOSTERONE KIT K842960ANDROSTENEDIONE BY RIA K840886HYDROXYPROGESTERONE BY RIA 17A K831855HATCH KIT K802195DEHYDROEPIANDROSTERONE SULFATE KIT RIA K791999(125I) TESTOSTERONE KIT

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Related Devices (Code: JLS)

K040923LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVAIbl GmbH K973898PROGESTERONE 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.