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FDA 510(k)

DCA 2000 SYSTEM FOR HEMOGLOBIN A1C

K-Number: K951361 · 1995-05-05

ApplicantHeraeus Kulzer, Inc.
Decision Date1995-05-05
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DCA 2000 SYSTEM FOR HEMOGLOBIN A1C 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 1995-05-05 under 510(k) number K951361. 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 DCA 2000 SYSTEM FOR HEMOGLOBIN A1C?

DCA 2000 SYSTEM FOR HEMOGLOBIN A1C is a medical device that received FDA 510(k) clearance on 1995-05-05. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K951361.

When did DCA 2000 SYSTEM FOR HEMOGLOBIN A1C receive FDA 510(k) clearance?

DCA 2000 SYSTEM FOR HEMOGLOBIN A1C received FDA 510(k) clearance on 1995-05-05, under 510(k) number K951361.

Who is the listed applicant for DCA 2000 SYSTEM FOR HEMOGLOBIN A1C?

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 DCA 2000 SYSTEM FOR HEMOGLOBIN A1C?

The FDA product code for DCA 2000 SYSTEM FOR HEMOGLOBIN A1C is LCP.

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Related Devices (Code: LCP)

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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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