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FDA 510(k)

BOEHRINGER MANNHEIM DIAGNOSTICS ADAM

K-Number: K843283 · 1984-10-05

ApplicantBoehringer Mannheim Corp.
Decision Date1984-10-05
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BOEHRINGER MANNHEIM DIAGNOSTICS ADAM is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1984-10-05 under 510(k) number K843283. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOEHRINGER MANNHEIM DIAGNOSTICS ADAM?

BOEHRINGER MANNHEIM DIAGNOSTICS ADAM is a medical device that received FDA 510(k) clearance on 1984-10-05. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K843283.

When did BOEHRINGER MANNHEIM DIAGNOSTICS ADAM receive FDA 510(k) clearance?

BOEHRINGER MANNHEIM DIAGNOSTICS ADAM received FDA 510(k) clearance on 1984-10-05, under 510(k) number K843283.

Who is the listed applicant for BOEHRINGER MANNHEIM DIAGNOSTICS ADAM?

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

What is the FDA product code for BOEHRINGER MANNHEIM DIAGNOSTICS ADAM?

The FDA product code for BOEHRINGER MANNHEIM DIAGNOSTICS ADAM is JJE.

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Other records listing Boehringer Mannheim Corp. as applicant

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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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