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FDA 510(k)

SIMULTANEOUS LH/FSH SYSTEM BY RIA

K-Number: K852376 · 1985-07-09

ApplicantAmerican Bioclinical, Inc.
Decision Date1985-07-09
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIMULTANEOUS LH/FSH SYSTEM BY RIA is the device name listed in this FDA 510(k) record. The listed applicant is American Bioclinical, Inc.. It received FDA 510(k) clearance on 1985-07-09 under 510(k) number K852376. 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 SIMULTANEOUS LH/FSH SYSTEM BY RIA?

SIMULTANEOUS LH/FSH SYSTEM BY RIA is a medical device that received FDA 510(k) clearance on 1985-07-09. The listed applicant is American Bioclinical, Inc.. The 510(k) number is K852376.

When did SIMULTANEOUS LH/FSH SYSTEM BY RIA receive FDA 510(k) clearance?

SIMULTANEOUS LH/FSH SYSTEM BY RIA received FDA 510(k) clearance on 1985-07-09, under 510(k) number K852376.

Who is the listed applicant for SIMULTANEOUS LH/FSH SYSTEM BY RIA?

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

What is the FDA product code for SIMULTANEOUS LH/FSH SYSTEM BY RIA?

The FDA product code for SIMULTANEOUS LH/FSH SYSTEM BY RIA is CEP.

Related Clinical Trials

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Other records listing American Bioclinical, Inc. 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.

K852939CORTISOL SYSTEM BY EIAK852437VISUAL SERUM/URINE HCG COMBO KITK851330PROLACTIN SYSTEM BY RIA

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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