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FDA 510(k)

ARCHITECT STAT MYO IMMUNOASSAY

K-Number: K042924 · 2005-01-24

ApplicantFisher Diagnostics
Decision Date2005-01-24
Product CodeDDR
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ARCHITECT STAT MYO IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Fisher Diagnostics. It received FDA 510(k) clearance on 2005-01-24 under 510(k) number K042924. The device is classified under product code DDR. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCHITECT STAT MYO IMMUNOASSAY?

ARCHITECT STAT MYO IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2005-01-24. The listed applicant is Fisher Diagnostics. The 510(k) number is K042924.

When did ARCHITECT STAT MYO IMMUNOASSAY receive FDA 510(k) clearance?

ARCHITECT STAT MYO IMMUNOASSAY received FDA 510(k) clearance on 2005-01-24, under 510(k) number K042924.

Who is the listed applicant for ARCHITECT STAT MYO IMMUNOASSAY?

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

What is the FDA product code for ARCHITECT STAT MYO IMMUNOASSAY?

The FDA product code for ARCHITECT STAT MYO IMMUNOASSAY is DDR.

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Other records listing Fisher Diagnostics 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.

K170652ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT ControlsK070640ARCHITECT STAT TROPONIN-1; MYOGLOBINK052407ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLSK052308ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROMK041192ARCHITECT STAT TROPONIN-I IMMUNOASSAYK041596ARCHITECT STAT CK-MB IMMUNOASSAY

View all 16 devices →

Related Devices (Code: DDR)

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.

K231832Access MyoglobinBeckman Coulter, Inc.K123785DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SETDiazyme LaboratoriesK122599ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATORSiemens Healthcare Diagnostics, Inc.K083260ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBINRoche DiagnosticsK080481ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORSBeckman Coulter, Inc.K061683TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEMRoche Diagnostics Corp.

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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