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FDA 510(k)

PARA-PAK

K-Number: K811377 · 1981-06-16

ApplicantMeridian Diagnostics, Inc.
Decision Date1981-06-16
Product CodeJTN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PARA-PAK 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 1981-06-16 under 510(k) number K811377. The device is classified under product code JTN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARA-PAK?

PARA-PAK is a medical device that received FDA 510(k) clearance on 1981-06-16. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K811377.

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

PARA-PAK received FDA 510(k) clearance on 1981-06-16, under 510(k) number K811377.

Who is the listed applicant for PARA-PAK?

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?

The FDA product code for PARA-PAK is JTN.

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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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