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FDA 510(k)

BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG

K-Number: K032713 · 2003-11-24

ApplicantBoston Biomedica, Inc.
Decision Date2003-11-24
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG 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 2003-11-24 under 510(k) number K032713. 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 BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG?

BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG is a medical device that received FDA 510(k) clearance on 2003-11-24. The listed applicant is Boston Biomedica, Inc.. The 510(k) number is K032713.

When did BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG receive FDA 510(k) clearance?

BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG received FDA 510(k) clearance on 2003-11-24, under 510(k) number K032713.

Who is the listed applicant for BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG?

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 BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG?

The FDA product code for BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG 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.

K980351BBI-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 CONTROLK972986ACCURUN 140 RUBELLA IGG POSITIVE CONTROL

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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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