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FDA 510(k)

PREMIER C. DIFFICILE TOXIN A CONTROLS

K-Number: K924136 · 1992-10-19

ApplicantMeridian Diagnostics, Inc.
Decision Date1992-10-19
Product CodeLLH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PREMIER C. DIFFICILE TOXIN A CONTROLS 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 1992-10-19 under 510(k) number K924136. The device is classified under product code LLH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREMIER C. DIFFICILE TOXIN A CONTROLS?

PREMIER C. DIFFICILE TOXIN A CONTROLS is a medical device that received FDA 510(k) clearance on 1992-10-19. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K924136.

When did PREMIER C. DIFFICILE TOXIN A CONTROLS receive FDA 510(k) clearance?

PREMIER C. DIFFICILE TOXIN A CONTROLS received FDA 510(k) clearance on 1992-10-19, under 510(k) number K924136.

Who is the listed applicant for PREMIER C. DIFFICILE TOXIN A CONTROLS?

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 PREMIER C. DIFFICILE TOXIN A CONTROLS?

The FDA product code for PREMIER C. DIFFICILE TOXIN A CONTROLS is LLH.

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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:H7K984346PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TESTK984343PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TESTK983255MODIFICATION TO: PREMIER PLATINUM HPSAK982764PREMIER CRYPTOSPORIDIUM

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Related Devices (Code: LLH)

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.

K193490SensiTox C. difficile Toxin TestFirst Light Diagnostics, Inc.K102242OSOM C. DIFFICILE TOXIN A/B TESTGenzyme CorporationK091109XPERT C. DIFFICILECepheidK090239PROGASTRO CD ASSAYProdesse, Inc.K082499C. DIFF QUIK CHEK COMPLETETechlab, Inc.K081920BD GENEOHM CDIFF ASSAYBd Diagnostics (Geneohm Sciences, 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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