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FDA 510(k)

TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)

K-Number: K930685 · 1993-06-22

ApplicantHeraeus Kulzer, Inc.
Decision Date1993-06-22
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.) 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 1993-06-22 under 510(k) number K930685. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.) is a medical device that received FDA 510(k) clearance on 1993-06-22. The listed applicant is Heraeus Kulzer, Inc.. The 510(k) number is K930685.

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

TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.) received FDA 510(k) clearance on 1993-06-22, under 510(k) number K930685.

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

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* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)?

The FDA product code for TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.) is GKL.

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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.

K091494FLEXITIME FLOWK063062HKBOND 2006K060994MONDIALK052543HERACERAM ZIRKONIAK043504PALAIMPACTK043295VERSYO.DIRECT

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Related Devices (Code: GKL)

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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