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FDA 510(k)

AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM

K-Number: K911625 · 1991-09-05

ApplicantHeraeus Kulzer, Inc.
Decision Date1991-09-05
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM 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 1991-09-05 under 510(k) number K911625. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM?

AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1991-09-05. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K911625.

When did AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM receive FDA 510(k) clearance?

AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM received FDA 510(k) clearance on 1991-09-05, under 510(k) number K911625.

Who is the listed applicant for AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM?

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 AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM?

The FDA product code for AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM is LCP.

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Other records listing Heraeus Kulzer, Inc. as applicant

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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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