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FDA 510(k)

TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1

K-Number: K925203 · 1992-11-25

ApplicantHeraeus Kulzer, Inc.
Decision Date1992-11-25
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1 is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Kulzer, Inc.. It received FDA 510(k) clearance on 1992-11-25 under 510(k) number K925203. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1?

TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1 is a medical device that received FDA 510(k) clearance on 1992-11-25. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K925203.

When did TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1 receive FDA 510(k) clearance?

TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1 received FDA 510(k) clearance on 1992-11-25, under 510(k) number K925203.

Who is the listed applicant for TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1?

The FDA 510(k) record lists Heraeus Kulzer, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1?

The FDA product code for TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1 is JJQ.

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Other records listing Heraeus Kulzer, Inc. as applicant

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Related Devices (Code: JJQ)

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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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