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FDA 510(k)

IMMUNOCARD MONO

K-Number: K930778 · 1993-12-27

ApplicantMeridian Diagnostics, Inc.
Decision Date1993-12-27
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNOCARD MONO 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 1993-12-27 under 510(k) number K930778. The device is classified under product code KTN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOCARD MONO?

IMMUNOCARD MONO is a medical device that received FDA 510(k) clearance on 1993-12-27. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K930778.

When did IMMUNOCARD MONO receive FDA 510(k) clearance?

IMMUNOCARD MONO received FDA 510(k) clearance on 1993-12-27, under 510(k) number K930778.

Who is the listed applicant for IMMUNOCARD MONO?

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 IMMUNOCARD MONO?

The FDA product code for IMMUNOCARD MONO is KTN.

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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: KTN)

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.

K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid TestSEKISUI Diagnostics, LLCK042272ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)ACON Laboratories, Inc.K030215BIORAPID MONONUCLEOSISInstrumentation Laboratory COK012901COLOR-MONOGENInstrumentation Laboratory COK982634DRYSPOT INFECTIOUS MONONUCLEOSIS KITOxoid , Ltd.K981946CLEARVIEW IMUnipath , Ltd.

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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