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FDA 510(k)

ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL

K-Number: K974811 · 1998-02-10

ApplicantBoston Biomedica, Inc.
Decision Date1998-02-10
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCURUN(TM) 150 HSV IGG 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 1998-02-10 under 510(k) number K974811. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL?

ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL is a medical device that received FDA 510(k) clearance on 1998-02-10. The listed applicant is Boston Biomedica, Inc.. The 510(k) number is K974811.

When did ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL receive FDA 510(k) clearance?

ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL received FDA 510(k) clearance on 1998-02-10, under 510(k) number K974811.

Who is the listed applicant for ACCURUN(TM) 150 HSV IGG 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(TM) 150 HSV IGG POSITIVE CONTROL?

The FDA product code for ACCURUN(TM) 150 HSV IGG POSITIVE CONTROL is JJX.

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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 KITK974809ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROLK974810ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROLK974261ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROLK972986ACCURUN 140 RUBELLA IGG POSITIVE CONTROL

View all 12 devices →

Related Devices (Code: JJX)

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.

K170678Beta-CrossLaps CalCheck 5Roche DiagnosticsK162173Elecsys CYFRA 21-1 CalCheck 5Roche DiagnosticsK162514Multichem A1cTechnopath ManufacturingK161874Audit MicroControls Linearity DROP LQ Blood GlucoseAalto Scientific, Ltd.K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.K161522LIAISON EBV IgM Serum Control SetDiaSorin, 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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