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FDA 510(k)

TECHNICON CHEM 1(TM) SYST (GEN2 SYST)

K-Number: K914888 · 1991-11-27

ApplicantTechnicon Instruments Corp.
Decision Date1991-11-27
Product CodeCIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TECHNICON CHEM 1(TM) SYST (GEN2 SYST) is the device name listed in this FDA 510(k) record. The listed applicant is Technicon Instruments Corp.. It received FDA 510(k) clearance on 1991-11-27 under 510(k) number K914888. The device is classified under product code CIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHNICON CHEM 1(TM) SYST (GEN2 SYST)?

TECHNICON CHEM 1(TM) SYST (GEN2 SYST) is a medical device that received FDA 510(k) clearance on 1991-11-27. The listed applicant is Technicon Instruments Corp.. The 510(k) number is K914888.

When did TECHNICON CHEM 1(TM) SYST (GEN2 SYST) receive FDA 510(k) clearance?

TECHNICON CHEM 1(TM) SYST (GEN2 SYST) received FDA 510(k) clearance on 1991-11-27, under 510(k) number K914888.

Who is the listed applicant for TECHNICON CHEM 1(TM) SYST (GEN2 SYST)?

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

What is the FDA product code for TECHNICON CHEM 1(TM) SYST (GEN2 SYST)?

The FDA product code for TECHNICON CHEM 1(TM) SYST (GEN2 SYST) is CIX.

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Other records listing Technicon Instruments Corp. as applicant

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Related Devices (Code: CIX)

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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