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FDA 510(k)

GAMMADAB LH RADIO-KIT #CA-1508

K-Number: K823476 · 1982-12-28

ApplicantClinical Assays, Inc.
Decision Date1982-12-28
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GAMMADAB LH RADIO-KIT #CA-1508 is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Assays, Inc.. It received FDA 510(k) clearance on 1982-12-28 under 510(k) number K823476. 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 GAMMADAB LH RADIO-KIT #CA-1508?

GAMMADAB LH RADIO-KIT #CA-1508 is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is Clinical Assays, Inc.. The 510(k) number is K823476.

When did GAMMADAB LH RADIO-KIT #CA-1508 receive FDA 510(k) clearance?

GAMMADAB LH RADIO-KIT #CA-1508 received FDA 510(k) clearance on 1982-12-28, under 510(k) number K823476.

Who is the listed applicant for GAMMADAB LH RADIO-KIT #CA-1508?

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

What is the FDA product code for GAMMADAB LH RADIO-KIT #CA-1508?

The FDA product code for GAMMADAB LH RADIO-KIT #CA-1508 is CEP.

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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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