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FDA 510(k)

SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT

K-Number: K875361 · 1988-05-13

ApplicantDisease Detection International, Inc.
Decision Date1988-05-13
Product CodeLFZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SERODOT CMV (CYTOMEGALOVIRUS) 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 1988-05-13 under 510(k) number K875361. The device is classified under product code LFZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT?

SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT is a medical device that received FDA 510(k) clearance on 1988-05-13. The listed applicant is Disease Detection International, Inc.. The 510(k) number is K875361.

When did SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT receive FDA 510(k) clearance?

SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT received FDA 510(k) clearance on 1988-05-13, under 510(k) number K875361.

Who is the listed applicant for SERODOT CMV (CYTOMEGALOVIRUS) 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 SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT?

The FDA product code for SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT is LFZ.

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Related Devices (Code: LFZ)

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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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