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FDA 510(k)

HEMOCHRON THROMBOCHRONOMETER

K-Number: K832189 · 1983-10-14

ApplicantInternational Technidyne Corp.
Decision Date1983-10-14
Product CodeJBP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOCHRON THROMBOCHRONOMETER is the device name listed in this FDA 510(k) record. The listed applicant is International Technidyne Corp.. It received FDA 510(k) clearance on 1983-10-14 under 510(k) number K832189. The device is classified under product code JBP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMOCHRON THROMBOCHRONOMETER?

HEMOCHRON THROMBOCHRONOMETER is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is International Technidyne Corp.. The 510(k) number is K832189.

When did HEMOCHRON THROMBOCHRONOMETER receive FDA 510(k) clearance?

HEMOCHRON THROMBOCHRONOMETER received FDA 510(k) clearance on 1983-10-14, under 510(k) number K832189.

Who is the listed applicant for HEMOCHRON THROMBOCHRONOMETER?

The FDA 510(k) record lists International Technidyne Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOCHRON THROMBOCHRONOMETER?

The FDA product code for HEMOCHRON THROMBOCHRONOMETER is JBP.

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Other records listing International Technidyne Corp. 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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