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FDA 510(k)

ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL

K-Number: K974810 · 1998-02-05

ApplicantBoston Biomedica, Inc.
Decision Date1998-02-05
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ACCURUN(TM) 132 BORRELIA BURDORFERI 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 1998-02-05 under 510(k) number K974810. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL?

ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL is a medical device that received FDA 510(k) clearance on 1998-02-05. The listed applicant is Boston Biomedica, Inc.. The 510(k) number is K974810.

When did ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL receive FDA 510(k) clearance?

ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL received FDA 510(k) clearance on 1998-02-05, under 510(k) number K974810.

Who is the listed applicant for ACCURUN(TM) 132 BORRELIA BURDORFERI 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(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL?

The FDA product code for ACCURUN(TM) 132 BORRELIA BURDORFERI IGM POSITIVE CONTROL is LSR.

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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 CONTROLK974809ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROLK974261ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROLK972986ACCURUN 140 RUBELLA IGG POSITIVE CONTROL

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Related Devices (Code: LSR)

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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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