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FDA 510(k)

PARA-PAK (C&S)

K-Number: K792712 · 1980-01-17

ApplicantMeridian Diagnostics, Inc.
Decision Date1980-01-17
Product CodeJSM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PARA-PAK (C&S) 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 1980-01-17 under 510(k) number K792712. The device is classified under product code JSM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARA-PAK (C&S)?

PARA-PAK (C&S) is a medical device that received FDA 510(k) clearance on 1980-01-17. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K792712.

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

PARA-PAK (C&S) received FDA 510(k) clearance on 1980-01-17, under 510(k) number K792712.

Who is the listed applicant for PARA-PAK (C&S)?

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 (C&S)?

The FDA product code for PARA-PAK (C&S) is JSM.

Other records listing Meridian Diagnostics, Inc. as applicant

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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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