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FDA 510(k)

BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT

K-Number: K980351 · 1999-03-05

ApplicantBoston Biomedica, Inc.
Decision Date1999-03-05
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT 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 1999-03-05 under 510(k) number K980351. 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 BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT?

BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT is a medical device that received FDA 510(k) clearance on 1999-03-05. The listed applicant is Boston Biomedica, Inc.. The 510(k) number is K980351.

When did BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT receive FDA 510(k) clearance?

BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT received FDA 510(k) clearance on 1999-03-05, under 510(k) number K980351.

Who is the listed applicant for BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT?

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 BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT?

The FDA product code for BBI-BIOTECH RESEARCH LABORATORIES B. BURGDORFERI IGM WESTERN BLOT KIT is LSR.

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Other records listing Boston Biomedica, Inc. as applicant

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K032713BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGGK974811ACCURUN(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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