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FDA 510(k)

TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL

K-Number: K970100 · 1997-03-10

ApplicantSimplicity Diagnostics, Inc.
Decision Date1997-03-10
Product CodeMJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Simplicity Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-03-10 under 510(k) number K970100. 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 TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL?

TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL is a medical device that received FDA 510(k) clearance on 1997-03-10. The listed applicant is Simplicity Diagnostics, Inc.. The 510(k) number is K970100.

When did TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL receive FDA 510(k) clearance?

TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL received FDA 510(k) clearance on 1997-03-10, under 510(k) number K970100.

Who is the listed applicant for TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL?

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

What is the FDA product code for TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL?

The FDA product code for TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL is MJX.

Related Clinical Trials

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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Other records listing Simplicity Diagnostics, 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.

K922726TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROLK922722TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROLK922725TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROLK922723TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL

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.K972986ACCURUN 140 RUBELLA IGG POSITIVE CONTROLBoston Biomedica, Inc.K934137OPUS(R) SEROLOGY CONTROLS, MODIFICATIONPb Diagnostic Systems, Inc.K925703OPUS SEROLOGY CONTROLSPb Diagnostics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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