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FDA 510(k)

ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL

K-Number: K972307 · 1997-08-07

ApplicantBoston Biomedica, Inc.
Decision Date1997-08-07
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) 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 1997-08-07 under 510(k) number K972307. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL?

ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL is a medical device that received FDA 510(k) clearance on 1997-08-07. The listed applicant is Boston Biomedica, Inc.. The 510(k) number is K972307.

When did ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL receive FDA 510(k) clearance?

ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL received FDA 510(k) clearance on 1997-08-07, under 510(k) number K972307.

Who is the listed applicant for ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) 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 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL?

The FDA product code for ACCURUN 119 ANTI-HEPATITIS B E ANTIGEN (ANTI-HBE) POSITIVE CONTROL is JJY.

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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: JJY)

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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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