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FDA 510(k)

PROGESTERONE SYSTEM BY EIA

K-Number: K864156 · 1986-11-24

ApplicantIntl. Bioclinical, Inc.
Decision Date1986-11-24
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROGESTERONE SYSTEM BY EIA is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Bioclinical, Inc.. It received FDA 510(k) clearance on 1986-11-24 under 510(k) number K864156. 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 SYSTEM BY EIA?

PROGESTERONE SYSTEM BY EIA is a medical device that received FDA 510(k) clearance on 1986-11-24. The listed applicant is Intl. Bioclinical, Inc.. The 510(k) number is K864156.

When did PROGESTERONE SYSTEM BY EIA receive FDA 510(k) clearance?

PROGESTERONE SYSTEM BY EIA received FDA 510(k) clearance on 1986-11-24, under 510(k) number K864156.

Who is the listed applicant for PROGESTERONE SYSTEM BY EIA?

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

What is the FDA product code for PROGESTERONE SYSTEM BY EIA?

The FDA product code for PROGESTERONE SYSTEM BY EIA is JLS.

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Other records listing Intl. Bioclinical, 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.

K913187INNOFLUOR(TM) DIGITOXIN REAGENT SETK913186INNOFLUOR(TM) DIGITOXIN CALIBRATOR SETK911688INNOFLUOR(TM) VALPROIC ACID REAGENT SETK911466INNOFLUOR VALPROIC ACID CALIBRATOR SETK883533ABC FP ANALYZER

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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