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FDA 510(k)

LEECO LH-QUANT DIAGNOSTIC KIT

K-Number: K810662 · 1981-03-31

ApplicantLeeco Diagnostics, Inc.
Decision Date1981-03-31
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LEECO LH-QUANT DIAGNOSTIC 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 1981-03-31 under 510(k) number K810662. The device is classified under product code CEP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEECO LH-QUANT DIAGNOSTIC KIT?

LEECO LH-QUANT DIAGNOSTIC KIT is a medical device that received FDA 510(k) clearance on 1981-03-31. The listed applicant is Leeco Diagnostics, Inc.. The 510(k) number is K810662.

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

LEECO LH-QUANT DIAGNOSTIC KIT received FDA 510(k) clearance on 1981-03-31, under 510(k) number K810662.

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

The FDA product code for LEECO LH-QUANT DIAGNOSTIC KIT is CEP.

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Other records listing Leeco Diagnostics, Inc. as applicant

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Related Devices (Code: CEP)

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.

K013582MAYBE?MOM MINI OVULATION MICROSCOPEMaybe?MomK022829INSTANT-VIEW LH OVULATION PREDICTING TESTAlfa Scientific Designs, Inc.K021409AT HOME OVULATION TEST, MODEL 9032Phamatech, Inc.K013874CLEARPLANE EASY OVULATION TESTUnipath , Ltd.K013323TCI-31 LIFELONG OVULATION TESTERTci New YorkK012252QUIK-CHECK OVULATION PREDICTORACON Laboratories, 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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