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FDA 510(k)

PARA-PAK PLUS

K-Number: K931770 · 1993-06-15

ApplicantMeridian Diagnostics, Inc.
Decision Date1993-06-15
Product CodeLIO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PARA-PAK PLUS 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 1993-06-15 under 510(k) number K931770. The device is classified under product code LIO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARA-PAK PLUS?

PARA-PAK PLUS is a medical device that received FDA 510(k) clearance on 1993-06-15. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K931770.

When did PARA-PAK PLUS receive FDA 510(k) clearance?

PARA-PAK PLUS received FDA 510(k) clearance on 1993-06-15, under 510(k) number K931770.

Who is the listed applicant for PARA-PAK PLUS?

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 PARA-PAK PLUS?

The FDA product code for PARA-PAK PLUS is LIO.

Other records listing Meridian Diagnostics, 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: LIO)

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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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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