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FDA 510(k)

LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT

K-Number: K850056 · 1985-02-06

ApplicantLeeco Diagnostics, Inc.
Decision Date1985-02-06
Product CodeJLS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Leeco Diagnostics, Inc.. It received FDA 510(k) clearance on 1985-02-06 under 510(k) number K850056. 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 LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT?

LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT is a medical device that received FDA 510(k) clearance on 1985-02-06. The listed applicant is Leeco Diagnostics, Inc.. The 510(k) number is K850056.

When did LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT receive FDA 510(k) clearance?

LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT received FDA 510(k) clearance on 1985-02-06, under 510(k) number K850056.

Who is the listed applicant for LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT?

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

What is the FDA product code for LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT?

The FDA product code for LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT is JLS.

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Other records listing Leeco 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.

K895765LEECO PREVIEW(R) EBV (EIA)K894122LEECO VIS-DISK STREP-A (EIA)K891095VIS-DISK HCG (EIA) LYOPHILIZED JPL-044MK891096VIS-DISK HCG (EIA) JPL-041MK883269PRL-QUANTK880577CONCEP-7-BHCG

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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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