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FDA 510(k)

PREMIER TOXINS A&B, MODEL 616096

K-Number: K993914 · 1999-12-10

ApplicantMeridian Diagnostics, Inc.
Decision Date1999-12-10
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PREMIER TOXINS A&B, MODEL 616096 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 1999-12-10 under 510(k) number K993914. The device is classified under product code LLH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIER TOXINS A&B, MODEL 616096?

PREMIER TOXINS A&B, MODEL 616096 is a medical device that received FDA 510(k) clearance on 1999-12-10. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K993914.

When did PREMIER TOXINS A&B, MODEL 616096 receive FDA 510(k) clearance?

PREMIER TOXINS A&B, MODEL 616096 received FDA 510(k) clearance on 1999-12-10, under 510(k) number K993914.

Who is the listed applicant for PREMIER TOXINS A&B, MODEL 616096?

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 PREMIER TOXINS A&B, MODEL 616096?

The FDA product code for PREMIER TOXINS A&B, MODEL 616096 is LLH.

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Other records listing Meridian Diagnostics, Inc. as applicant

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Related Devices (Code: LLH)

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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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