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FDA 510(k)

ACCURUN 146 CMV IGM POSITIVE CONTROL

K-Number: K972884 · 1997-08-22

ApplicantBoston Biomedica, Inc.
Decision Date1997-08-22
Product CodeLKQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ACCURUN 146 CMV IGM POSITIVE CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Boston Biomedica, Inc.. It received FDA 510(k) clearance on 1997-08-22 under 510(k) number K972884. The device is classified under product code LKQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCURUN 146 CMV IGM POSITIVE CONTROL?

ACCURUN 146 CMV IGM POSITIVE CONTROL is a medical device that received FDA 510(k) clearance on 1997-08-22. The listed applicant is Boston Biomedica, Inc.. The 510(k) number is K972884.

When did ACCURUN 146 CMV IGM POSITIVE CONTROL receive FDA 510(k) clearance?

ACCURUN 146 CMV IGM POSITIVE CONTROL received FDA 510(k) clearance on 1997-08-22, under 510(k) number K972884.

Who is the listed applicant for ACCURUN 146 CMV IGM POSITIVE CONTROL?

The FDA 510(k) record lists Boston Biomedica, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCURUN 146 CMV IGM POSITIVE CONTROL?

The FDA product code for ACCURUN 146 CMV IGM POSITIVE CONTROL is LKQ.

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Other records listing Boston Biomedica, 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.

K032713BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGGK980351BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KITK974811ACCURUN(TM) 150 HSV IGG POSITIVE CONTROLK974810ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROLK974809ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROLK974261ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL

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Related Devices (Code: LKQ)

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.

K100433IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,Siemens Healthcare DiagnosticsK933549VIDAS CMV IGM ASSAYBiomerieux Vitek, Inc.K922580BARTELS CYTOMEGALOVIRUS IGM EIABaxter Diagnostics, Inc.K914789ELISA CMV IGMSclavo, Inc.K913080OPUS(R) ANTI CMV-MPb Diagnostics, Inc.K900743CMV-IGM IFA TEST SYSTEMZeus Scientific, 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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