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FDA 510(k)

RIA KIT, LH

K-Number: K781685 · 1978-10-27

ApplicantAmersham Corp.
Decision Date1978-10-27
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RIA KIT, LH is the device name listed in this FDA 510(k) record. The listed applicant is Amersham Corp.. It received FDA 510(k) clearance on 1978-10-27 under 510(k) number K781685. 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 RIA KIT, LH?

RIA KIT, LH is a medical device that received FDA 510(k) clearance on 1978-10-27. The listed applicant is Amersham Corp.. The 510(k) number is K781685.

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

RIA KIT, LH received FDA 510(k) clearance on 1978-10-27, under 510(k) number K781685.

Who is the listed applicant for RIA KIT, LH?

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

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

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

Other records listing Amersham Corp. 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.

K914135AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086K912733AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KITK912766AMERLITE CK-MB ASSAYK904666AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008K902760AMERSHAM TSH CONTROL SERAK901848GADOLINIUM-153 BONE DENSITOMETER SOURCES

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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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