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FDA 510(k)

BHCG-ROCHE EIA

K-Number: K850727 · 1985-06-25

ApplicantHoffmann-La Roche, Inc.
Decision Date1985-06-25
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BHCG-ROCHE EIA is the device name listed in this FDA 510(k) record. The listed applicant is Hoffmann-La Roche, Inc.. It received FDA 510(k) clearance on 1985-06-25 under 510(k) number K850727. 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 BHCG-ROCHE EIA?

BHCG-ROCHE EIA is a medical device that received FDA 510(k) clearance on 1985-06-25. The listed applicant is Hoffmann-La Roche, Inc.. The 510(k) number is K850727.

When did BHCG-ROCHE EIA receive FDA 510(k) clearance?

BHCG-ROCHE EIA received FDA 510(k) clearance on 1985-06-25, under 510(k) number K850727.

Who is the listed applicant for BHCG-ROCHE EIA?

The FDA 510(k) record lists Hoffmann-La Roche, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BHCG-ROCHE EIA?

The FDA product code for BHCG-ROCHE EIA is JHI.

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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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