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FDA 510(k)

LH QUIK RIA KIT

K-Number: K840174 · 1984-03-19

ApplicantPacific Biotech, Inc.
Decision Date1984-03-19
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LH QUIK RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Biotech, Inc.. It received FDA 510(k) clearance on 1984-03-19 under 510(k) number K840174. 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 LH QUIK RIA KIT?

LH QUIK RIA KIT is a medical device that received FDA 510(k) clearance on 1984-03-19. The listed applicant is Pacific Biotech, Inc.. The 510(k) number is K840174.

When did LH QUIK RIA KIT receive FDA 510(k) clearance?

LH QUIK RIA KIT received FDA 510(k) clearance on 1984-03-19, under 510(k) number K840174.

Who is the listed applicant for LH QUIK RIA KIT?

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

What is the FDA product code for LH QUIK RIA KIT?

The FDA product code for LH QUIK RIA KIT is CEP.

Other records listing Pacific Biotech, 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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