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FDA 510(k)

ASPERGILLUS SP, COMPLEMENT FIXATION

K-Number: K792700 · 1980-01-17

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

Device Summary

ASPERGILLUS SP, COMPLEMENT FIXATION 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 K792700. The device is classified under product code JWT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASPERGILLUS SP, COMPLEMENT FIXATION?

ASPERGILLUS SP, COMPLEMENT FIXATION 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 K792700.

When did ASPERGILLUS SP, COMPLEMENT FIXATION receive FDA 510(k) clearance?

ASPERGILLUS SP, COMPLEMENT FIXATION received FDA 510(k) clearance on 1980-01-17, under 510(k) number K792700.

Who is the listed applicant for ASPERGILLUS SP, COMPLEMENT FIXATION?

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 ASPERGILLUS SP, COMPLEMENT FIXATION?

The FDA product code for ASPERGILLUS SP, COMPLEMENT FIXATION is JWT.

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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: JWT)

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.

K812740REAGENTS FOR SERODIAGNOSIS OF ASPERGILLNolan Biological Laboratories, Inc.K791387ASPERGILLUS MYCELIAL ANTIGEN #CF10024XImmuno-Mycologics, Inc.K790672ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVUDiagnostica, Inc.K760830ASPERGILLUS MYCELIAL ANTIGENI M, 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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