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FDA 510(k)

MICROMEDIC LH & FSH RIA KIT

K-Number: K840188 · 1984-03-23

ApplicantMicromedic Systems
Decision Date1984-03-23
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICROMEDIC LH & FSH RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Micromedic Systems. It received FDA 510(k) clearance on 1984-03-23 under 510(k) number K840188. 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 MICROMEDIC LH & FSH RIA KIT?

MICROMEDIC LH & FSH RIA KIT is a medical device that received FDA 510(k) clearance on 1984-03-23. The listed applicant is Micromedic Systems. The 510(k) number is K840188.

When did MICROMEDIC LH & FSH RIA KIT receive FDA 510(k) clearance?

MICROMEDIC LH & FSH RIA KIT received FDA 510(k) clearance on 1984-03-23, under 510(k) number K840188.

Who is the listed applicant for MICROMEDIC LH & FSH RIA KIT?

The FDA 510(k) record lists Micromedic Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICROMEDIC LH & FSH RIA KIT?

The FDA product code for MICROMEDIC LH & FSH RIA KIT is CEP.

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Other records listing Micromedic Systems 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.

K923643MEDICOOLK872309MICROMEDIC COMBOSTAT LH/FSH KITK871008MICROMEDIC NEONATAL T4 KITK870904MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KITK871505AUTOPAK NEONATAL TSH MONOCLONAL IRMA KITK870245AUTOPAK TSH MONOCLONAL IRMA KIT

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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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