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FDA 510(k)

HSV-CHECK(TM) TEST KIT

K-Number: K890819 · 1989-06-20

ApplicantDiagnostic Technology, Inc.
Decision Date1989-06-20
Product CodeHIS
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HSV-CHECK(TM) TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Technology, Inc.. It received FDA 510(k) clearance on 1989-06-20 under 510(k) number K890819. The device is classified under product code HIS. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HSV-CHECK(TM) TEST KIT?

HSV-CHECK(TM) TEST KIT is a medical device that received FDA 510(k) clearance on 1989-06-20. The listed applicant is Diagnostic Technology, Inc.. The 510(k) number is K890819.

When did HSV-CHECK(TM) TEST KIT receive FDA 510(k) clearance?

HSV-CHECK(TM) TEST KIT received FDA 510(k) clearance on 1989-06-20, under 510(k) number K890819.

Who is the listed applicant for HSV-CHECK(TM) TEST KIT?

The FDA 510(k) record lists Diagnostic Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HSV-CHECK(TM) TEST KIT?

The FDA product code for HSV-CHECK(TM) TEST KIT is HIS.

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Other records listing Diagnostic Technology, 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.

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Related Devices (Code: HIS)

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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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