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FDA 510(k)

SYSCOS IDC - G, IDC, BSC, IDC - G

K-Number: K974262 · 1997-12-24

ApplicantScantibodies Laboratory, Inc.
Decision Date1997-12-24
Product CodeMJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYSCOS IDC - G, IDC, BSC, IDC - G is the device name listed in this FDA 510(k) record. The listed applicant is Scantibodies Laboratory, Inc.. It received FDA 510(k) clearance on 1997-12-24 under 510(k) number K974262. 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 SYSCOS IDC - G, IDC, BSC, IDC - G?

SYSCOS IDC - G, IDC, BSC, IDC - G is a medical device that received FDA 510(k) clearance on 1997-12-24. The listed applicant is Scantibodies Laboratory, Inc.. The 510(k) number is K974262.

When did SYSCOS IDC - G, IDC, BSC, IDC - G receive FDA 510(k) clearance?

SYSCOS IDC - G, IDC, BSC, IDC - G received FDA 510(k) clearance on 1997-12-24, under 510(k) number K974262.

Who is the listed applicant for SYSCOS IDC - G, IDC, BSC, IDC - G?

The FDA 510(k) record lists Scantibodies Laboratory, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYSCOS IDC - G, IDC, BSC, IDC - G?

The FDA product code for SYSCOS IDC - G, IDC, BSC, IDC - G is MJX.

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Other records listing Scantibodies Laboratory, 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.

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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 DiagnosticsK972986ACCURUN 140 RUBELLA IGG POSITIVE CONTROLBoston Biomedica, 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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