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FDA 510(k)

PARA-PAK(WHEATLEY'S TRICHROME STAIN)

K-Number: K792706 · 1980-01-24

ApplicantMeridian Diagnostics, Inc.
Decision Date1980-01-24
Product CodeHYW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PARA-PAK(WHEATLEY'S TRICHROME STAIN) 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 K792706. The device is classified under product code HYW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PARA-PAK(WHEATLEY'S TRICHROME STAIN)?

PARA-PAK(WHEATLEY'S TRICHROME STAIN) 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 K792706.

When did PARA-PAK(WHEATLEY'S TRICHROME STAIN) receive FDA 510(k) clearance?

PARA-PAK(WHEATLEY'S TRICHROME STAIN) received FDA 510(k) clearance on 1980-01-24, under 510(k) number K792706.

Who is the listed applicant for PARA-PAK(WHEATLEY'S TRICHROME STAIN)?

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(WHEATLEY'S TRICHROME STAIN)?

The FDA product code for PARA-PAK(WHEATLEY'S TRICHROME STAIN) is HYW.

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Other records listing Meridian Diagnostics, Inc. as applicant

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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: HYW)

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.

K781062DROPPER, SOLUTION TRICHROME, CEPTI-SEALMarion 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.

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