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FDA 510(k)

TECHNICON CHEM 1 PLASMA GLUCOSE

K-Number: K914794 · 1991-12-18

ApplicantHeraeus Kulzer, Inc.
Decision Date1991-12-18
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TECHNICON CHEM 1 PLASMA GLUCOSE 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 1991-12-18 under 510(k) number K914794. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHNICON CHEM 1 PLASMA GLUCOSE?

TECHNICON CHEM 1 PLASMA GLUCOSE is a medical device that received FDA 510(k) clearance on 1991-12-18. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K914794.

When did TECHNICON CHEM 1 PLASMA GLUCOSE receive FDA 510(k) clearance?

TECHNICON CHEM 1 PLASMA GLUCOSE received FDA 510(k) clearance on 1991-12-18, under 510(k) number K914794.

Who is the listed applicant for TECHNICON CHEM 1 PLASMA GLUCOSE?

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 PLASMA GLUCOSE?

The FDA product code for TECHNICON CHEM 1 PLASMA GLUCOSE is CFR.

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Other records listing Heraeus Kulzer, Inc. as applicant

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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Related Devices (Code: CFR)

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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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