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FDA 510(k)

TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)

K-Number: K930148 · 1993-05-11

ApplicantHeraeus Kulzer, Inc.
Decision Date1993-05-11
Product CodeGKZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. 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 1993-05-11 under 510(k) number K930148. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)?

TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM) is a medical device that received FDA 510(k) clearance on 1993-05-11. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K930148.

When did TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM) receive FDA 510(k) clearance?

TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM) received FDA 510(k) clearance on 1993-05-11, under 510(k) number K930148.

Who is the listed applicant for TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. 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 TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)?

The FDA product code for TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM) is GKZ.

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Other records listing Heraeus Kulzer, Inc. as applicant

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Related Devices (Code: GKZ)

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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