FDA 510(k)

PARA-PAK PVA

K-Number: K792714 · 1980-01-24

Decision Date1980-01-24

Product CodeIFQ

Advisory CommitteePA

DecisionSubstantially Equivalent

Device Summary

PARA-PAK PVA 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 1980-01-24 under 510(k) number K792714. The device is classified under product code IFQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARA-PAK PVA?

PARA-PAK PVA is a medical device that received FDA 510(k) clearance on 1980-01-24. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K792714.

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

PARA-PAK PVA received FDA 510(k) clearance on 1980-01-24, under 510(k) number K792714.

Who is the listed applicant for PARA-PAK PVA?

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 PVA?

The FDA product code for PARA-PAK PVA is IFQ.

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.

K993914PREMIER TOXINS A&B, MODEL 616096 K990263IMMUNOCARD STAT! E. COLI O157:H7 K984343PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST K984346PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST K983255MODIFICATION TO: PREMIER PLATINUM HPSA K982764PREMIER CRYPTOSPORIDIUM

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Related Devices (Code: IFQ)

K792654CULTURETTE BRAND-PVA/FORMALIN KITMarion Laboratories, Inc.

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.