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FDA 510(k)

PROGESTERONE RADIOIMMUNOASSAY KIT

K-Number: K791051 · 1979-07-24

ApplicantCis Radiopharmaceuticals, Inc.
Decision Date1979-07-24
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROGESTERONE RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Cis Radiopharmaceuticals, Inc.. It received FDA 510(k) clearance on 1979-07-24 under 510(k) number K791051. 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 RADIOIMMUNOASSAY KIT?

PROGESTERONE RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1979-07-24. The listed applicant is Cis Radiopharmaceuticals, Inc.. The 510(k) number is K791051.

When did PROGESTERONE RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

PROGESTERONE RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1979-07-24, under 510(k) number K791051.

Who is the listed applicant for PROGESTERONE RADIOIMMUNOASSAY KIT?

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

What is the FDA product code for PROGESTERONE RADIOIMMUNOASSAY KIT?

The FDA product code for PROGESTERONE RADIOIMMUNOASSAY KIT is JLS.

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Other records listing Cis Radiopharmaceuticals, 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.

K791860FERRITIN RIA KITK792063FOLLICLE STIMULATING HORMONE (FSH) KITK791202RIA KIT FOR TRYPSINK792000LUTEINIZING HORMONE (LH) RIAK790003RIA KIT, PROLACTINK780982KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT

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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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