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FDA 510(k)

LH/FSH RADIOIMMUNOASSAY KIT

K-Number: K853837 · 1985-10-16

ApplicantBioclinical Group
Decision Date1985-10-16
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LH/FSH RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bioclinical Group. It received FDA 510(k) clearance on 1985-10-16 under 510(k) number K853837. 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/FSH RADIOIMMUNOASSAY KIT?

LH/FSH RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1985-10-16. The listed applicant is Bioclinical Group. The 510(k) number is K853837.

When did LH/FSH RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

LH/FSH RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1985-10-16, under 510(k) number K853837.

Who is the listed applicant for LH/FSH RADIOIMMUNOASSAY KIT?

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

What is the FDA product code for LH/FSH RADIOIMMUNOASSAY KIT?

The FDA product code for LH/FSH RADIOIMMUNOASSAY KIT is CEP.

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Other records listing Bioclinical Group 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.

K862968FREE T3 RADIOIMMUNOASSAY KITK832638CORTISOL RADIOIMMUNOASSAY KITK823005BIO MAG FREE T4 RADIOIMMUNOASSAY KITK823004BIO MAG TOTAL T4 RADIOIMMUNOASSAY KITK822840RADIOIMMUNOASSAY, HUMAN CHORRIONICK822515B-HCG RADIOIMMUNOASSAY 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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