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FDA 510(k)

COTUBE HCG IRMA TEST

K-Number: K882155 · 1988-08-08

ApplicantBio-Rad
Decision Date1988-08-08
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COTUBE HCG IRMA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1988-08-08 under 510(k) number K882155. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COTUBE HCG IRMA TEST?

COTUBE HCG IRMA TEST is a medical device that received FDA 510(k) clearance on 1988-08-08. The listed applicant is Bio-Rad. The 510(k) number is K882155.

When did COTUBE HCG IRMA TEST receive FDA 510(k) clearance?

COTUBE HCG IRMA TEST received FDA 510(k) clearance on 1988-08-08, under 510(k) number K882155.

Who is the listed applicant for COTUBE HCG IRMA TEST?

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

What is the FDA product code for COTUBE HCG IRMA TEST?

The FDA product code for COTUBE HCG IRMA TEST is JHI.

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Related Devices (Code: JHI)

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.

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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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