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FDA 510(k)

HITACHI 914 ANALYZER

K-Number: K942364 · 1994-10-04

ApplicantBoehringer Mannheim Corp.
Decision Date1994-10-04
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HITACHI 914 ANALYZER 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 1994-10-04 under 510(k) number K942364. 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 HITACHI 914 ANALYZER?

HITACHI 914 ANALYZER is a medical device that received FDA 510(k) clearance on 1994-10-04. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K942364.

When did HITACHI 914 ANALYZER receive FDA 510(k) clearance?

HITACHI 914 ANALYZER received FDA 510(k) clearance on 1994-10-04, under 510(k) number K942364.

Who is the listed applicant for HITACHI 914 ANALYZER?

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 HITACHI 914 ANALYZER?

The FDA product code for HITACHI 914 ANALYZER is JJE.

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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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