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FDA 510(k)

ACCURUN 140 RUBELLA IGG POSITIVE CONTROL

K-Number: K972986 · 1997-10-08

ApplicantBoston Biomedica, Inc.
Decision Date1997-10-08
Product CodeMJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCURUN 140 RUBELLA 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 1997-10-08 under 510(k) number K972986. The device is classified under product code MJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCURUN 140 RUBELLA IGG POSITIVE CONTROL?

ACCURUN 140 RUBELLA IGG POSITIVE CONTROL is a medical device that received FDA 510(k) clearance on 1997-10-08. The listed applicant is Boston Biomedica, Inc.. The 510(k) number is K972986.

When did ACCURUN 140 RUBELLA IGG POSITIVE CONTROL receive FDA 510(k) clearance?

ACCURUN 140 RUBELLA IGG POSITIVE CONTROL received FDA 510(k) clearance on 1997-10-08, under 510(k) number K972986.

Who is the listed applicant for ACCURUN 140 RUBELLA 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 140 RUBELLA IGG POSITIVE CONTROL?

The FDA product code for ACCURUN 140 RUBELLA IGG POSITIVE CONTROL is MJX.

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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

View all 12 devices →

Related Devices (Code: MJX)

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.

K101434AUDIT MICROCV PROCALCITONIN LINEARITYAalto Scientific, Ltd.K030067VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLSOrtho-Clinical DiagnosticsK974262SYSCOS IDC - G, IDC, BSC, IDC - GScantibodies Laboratory, Inc.K970100TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROLSimplicity Diagnostics, Inc.K934137OPUS(R) SEROLOGY CONTROLS, MODIFICATIONPb Diagnostic Systems, Inc.K925703OPUS SEROLOGY CONTROLSPb Diagnostics, 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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