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FDA 510(k)

HITACHI 705 AUTOMATIC BLOOD CHEMISTRY

K-Number: K811194 · 1981-05-27

ApplicantBoehringer Mannheim Corp.
Decision Date1981-05-27
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HITACHI 705 AUTOMATIC BLOOD CHEMISTRY 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 1981-05-27 under 510(k) number K811194. 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 705 AUTOMATIC BLOOD CHEMISTRY?

HITACHI 705 AUTOMATIC BLOOD CHEMISTRY is a medical device that received FDA 510(k) clearance on 1981-05-27. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K811194.

When did HITACHI 705 AUTOMATIC BLOOD CHEMISTRY receive FDA 510(k) clearance?

HITACHI 705 AUTOMATIC BLOOD CHEMISTRY received FDA 510(k) clearance on 1981-05-27, under 510(k) number K811194.

Who is the listed applicant for HITACHI 705 AUTOMATIC BLOOD CHEMISTRY?

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 705 AUTOMATIC BLOOD CHEMISTRY?

The FDA product code for HITACHI 705 AUTOMATIC BLOOD CHEMISTRY 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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