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FDA 510(k)

PROGESTERONE ELISA

K-Number: K973898 · 1997-11-13

ApplicantKmi Diagnostics, Inc.
Decision Date1997-11-13
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROGESTERONE ELISA is the device name listed in this FDA 510(k) record. The listed applicant is Kmi Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-11-13 under 510(k) number K973898. 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 ELISA?

PROGESTERONE ELISA is a medical device that received FDA 510(k) clearance on 1997-11-13. The listed applicant is Kmi Diagnostics, Inc.. The 510(k) number is K973898.

When did PROGESTERONE ELISA receive FDA 510(k) clearance?

PROGESTERONE ELISA received FDA 510(k) clearance on 1997-11-13, under 510(k) number K973898.

Who is the listed applicant for PROGESTERONE ELISA?

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

What is the FDA product code for PROGESTERONE ELISA?

The FDA product code for PROGESTERONE ELISA is JLS.

Related Clinical Trials

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.

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Other records listing Kmi Diagnostics, 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.

K010790CORTISOL LIAK990073CALCITONINK973900TESTOTERONE ELISAK97390117 B-ESTRADIOL (ELISA)K973897DHEA-S

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 GmbHK972133VITROS 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.K955025AXSYM PROGESTERONEAbbott Laboratories

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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