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FDA 510(k)

ENDO-STAPH TEICHOIC ACID ANTIBODY KIT

K-Number: K820531 · 1982-04-14

ApplicantMeridian Diagnostics, Inc.
Decision Date1982-04-14
Product CodeLHT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENDO-STAPH TEICHOIC ACID ANTIBODY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Diagnostics, Inc.. It received FDA 510(k) clearance on 1982-04-14 under 510(k) number K820531. The device is classified under product code LHT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDO-STAPH TEICHOIC ACID ANTIBODY KIT?

ENDO-STAPH TEICHOIC ACID ANTIBODY KIT is a medical device that received FDA 510(k) clearance on 1982-04-14. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K820531.

When did ENDO-STAPH TEICHOIC ACID ANTIBODY KIT receive FDA 510(k) clearance?

ENDO-STAPH TEICHOIC ACID ANTIBODY KIT received FDA 510(k) clearance on 1982-04-14, under 510(k) number K820531.

Who is the listed applicant for ENDO-STAPH TEICHOIC ACID ANTIBODY KIT?

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

What is the FDA product code for ENDO-STAPH TEICHOIC ACID ANTIBODY KIT?

The FDA product code for ENDO-STAPH TEICHOIC ACID ANTIBODY KIT is LHT.

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Related Devices (Code: LHT)

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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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