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FDA 510(k)

HYDROXYPROGESTERONE-17

K-Number: K832297 · 1983-09-01

ApplicantDiagnostics Biochem Canada, Inc.
Decision Date1983-09-01
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HYDROXYPROGESTERONE-17 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostics Biochem Canada, Inc.. It received FDA 510(k) clearance on 1983-09-01 under 510(k) number K832297. 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-17?

HYDROXYPROGESTERONE-17 is a medical device that received FDA 510(k) clearance on 1983-09-01. The listed applicant is Diagnostics Biochem Canada, Inc.. The 510(k) number is K832297.

When did HYDROXYPROGESTERONE-17 receive FDA 510(k) clearance?

HYDROXYPROGESTERONE-17 received FDA 510(k) clearance on 1983-09-01, under 510(k) number K832297.

Who is the listed applicant for HYDROXYPROGESTERONE-17?

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

What is the FDA product code for HYDROXYPROGESTERONE-17?

The FDA product code for HYDROXYPROGESTERONE-17 is JLS.

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Other records listing Diagnostics Biochem Canada, 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.

K030730FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KITK014120TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)K864966ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONEK801729ANDROSTENEDIONE RADIOIMMUNOASSAY KITK781310HUMAN CHORIONIC GONADO.-BETA RIA KIT

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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