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FDA 510(k)

RIA-GNOST PROGESTERONE

K-Number: K890836 · 1989-03-16

ApplicantCambridge Medical Technology
Decision Date1989-03-16
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIA-GNOST PROGESTERONE is the device name listed in this FDA 510(k) record. The listed applicant is Cambridge Medical Technology. It received FDA 510(k) clearance on 1989-03-16 under 510(k) number K890836. 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 RIA-GNOST PROGESTERONE?

RIA-GNOST PROGESTERONE is a medical device that received FDA 510(k) clearance on 1989-03-16. The listed applicant is Cambridge Medical Technology. The 510(k) number is K890836.

When did RIA-GNOST PROGESTERONE receive FDA 510(k) clearance?

RIA-GNOST PROGESTERONE received FDA 510(k) clearance on 1989-03-16, under 510(k) number K890836.

Who is the listed applicant for RIA-GNOST PROGESTERONE?

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

What is the FDA product code for RIA-GNOST PROGESTERONE?

The FDA product code for RIA-GNOST PROGESTERONE is JLS.

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Other records listing Cambridge Medical Technology 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.

K890837RIA-GNOST INSULINK890697RIA-GNOST FERRITINK873737NO SPIN(TM) T3 COATED TUBE RADIOIMMUNOASSAYK870573T4 NO SPIN(TM) COATED TUBE RADIOIMMUNOASSAY KITK862871RADIOIMMUNOASSAY OF NO SPIN(TM) CORTISOLK860130TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY 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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