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FDA 510(k)

THE DDI SERODOT HERPES IGG TEST KIT

K-Number: K875366 · 1988-05-23

ApplicantDisease Detection International, Inc.
Decision Date1988-05-23
Product CodeGQO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

THE DDI SERODOT HERPES IGG TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Disease Detection International, Inc.. It received FDA 510(k) clearance on 1988-05-23 under 510(k) number K875366. The device is classified under product code GQO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE DDI SERODOT HERPES IGG TEST KIT?

THE DDI SERODOT HERPES IGG TEST KIT is a medical device that received FDA 510(k) clearance on 1988-05-23. The listed applicant is Disease Detection International, Inc.. The 510(k) number is K875366.

When did THE DDI SERODOT HERPES IGG TEST KIT receive FDA 510(k) clearance?

THE DDI SERODOT HERPES IGG TEST KIT received FDA 510(k) clearance on 1988-05-23, under 510(k) number K875366.

Who is the listed applicant for THE DDI SERODOT HERPES IGG TEST KIT?

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

What is the FDA product code for THE DDI SERODOT HERPES IGG TEST KIT?

The FDA product code for THE DDI SERODOT HERPES IGG TEST KIT is GQO.

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Related Devices (Code: GQO)

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K883281VIRGO HSV-2 IGG ELISAElectro-Nucleonics, Inc.K883282VIRGO HSV-1 IGG ELISAElectro-Nucleonics, Inc.K881261BION HSV1-G OR HSV2-G TEST SYSTEMBion Ent., Ltd.K871426VIROGEN HSV ANTIBODY TESTArmkel, LLCK861120THE GOLDEN QUAD TEST (HSV)Microbiological Research Corp.K854712VISIBLE-HERPES TM TEST SYSTEMIsolab, Inc.

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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