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FDA 510(k)

PARA-PAK FORMALIN

K-Number: K792705 · 1980-01-21

ApplicantMeridian Diagnostics, Inc.
Decision Date1980-01-21
Product CodeIGG
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

PARA-PAK FORMALIN 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 1980-01-21 under 510(k) number K792705. The device is classified under product code IGG. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARA-PAK FORMALIN?

PARA-PAK FORMALIN is a medical device that received FDA 510(k) clearance on 1980-01-21. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K792705.

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

PARA-PAK FORMALIN received FDA 510(k) clearance on 1980-01-21, under 510(k) number K792705.

Who is the listed applicant for PARA-PAK FORMALIN?

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 FORMALIN?

The FDA product code for PARA-PAK FORMALIN is IGG.

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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 616096K990263IMMUNOCARD STAT! E. COLI O157:H7K984343PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TESTK984346PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TESTK983255MODIFICATION TO: PREMIER PLATINUM HPSAK982764PREMIER CRYPTOSPORIDIUM

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Related Devices (Code: IGG)

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.

K882268ZINC FORMALIN CONCENTRATEAnatech, Ltd.K861201FORMALDEHYDE SOLUTION, 37%Surgipath Medical Industries, Inc.K81179437% FORMALDEHYDERichard-Allan Medical Ind., Inc.K802506PLEASCENT OR FORMA-SCENTMeridian Diagnostics, Inc.K792707PARA-PAK SAFMeridian Diagnostics, Inc.K771201FORMALIN BUFFER CONCENTRATECentral Labs. Assoc. MD Pathologists

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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