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FDA 510(k)

MODIFIED COTROPIN RADIOIMMUNOASSAY KIT

K-Number: K862180 · 1986-07-07

ApplicantClinetics Corp.
Decision Date1986-07-07
Product CodeCEP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFIED COTROPIN RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Clinetics Corp.. It received FDA 510(k) clearance on 1986-07-07 under 510(k) number K862180. 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 MODIFIED COTROPIN RADIOIMMUNOASSAY KIT?

MODIFIED COTROPIN RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1986-07-07. The listed applicant is Clinetics Corp.. The 510(k) number is K862180.

When did MODIFIED COTROPIN RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

MODIFIED COTROPIN RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1986-07-07, under 510(k) number K862180.

Who is the listed applicant for MODIFIED COTROPIN RADIOIMMUNOASSAY KIT?

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

What is the FDA product code for MODIFIED COTROPIN RADIOIMMUNOASSAY KIT?

The FDA product code for MODIFIED COTROPIN RADIOIMMUNOASSAY KIT is CEP.

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Other records listing Clinetics 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.

K844066COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSHK841580TSH RECEPTOR ANTIBODY KIT 125I TSHK833934ADRENOCORTICOTROPIC HORMONE TESTK830357RADIOIMMUNOASSAY IMMUNOGLOBULINS D.EK823380125-I LH RADIOIMMUNOASSAY KITK823379125-I FSH 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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