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FDA 510(k)

ARCHITECT STAT TROPONIN-I IMMUNOASSAY

K-Number: K041192 · 2004-08-12

ApplicantFisher Diagnostics
Decision Date2004-08-12
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ARCHITECT STAT TROPONIN-I 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 2004-08-12 under 510(k) number K041192. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCHITECT STAT TROPONIN-I IMMUNOASSAY?

ARCHITECT STAT TROPONIN-I IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2004-08-12. The listed applicant is Fisher Diagnostics. The 510(k) number is K041192.

When did ARCHITECT STAT TROPONIN-I IMMUNOASSAY receive FDA 510(k) clearance?

ARCHITECT STAT TROPONIN-I IMMUNOASSAY received FDA 510(k) clearance on 2004-08-12, under 510(k) number K041192.

Who is the listed applicant for ARCHITECT STAT TROPONIN-I 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 TROPONIN-I IMMUNOASSAY?

The FDA product code for ARCHITECT STAT TROPONIN-I IMMUNOASSAY is MMI.

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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-ROMK042924ARCHITECT STAT MYO IMMUNOASSAYK041596ARCHITECT STAT CK-MB IMMUNOASSAY

View all 16 devices →

Related Devices (Code: MMI)

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.

K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc.K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc.K243483Access hsTnIBeckman Coulter, Inc.K242870Access hsTnIBeckman Coulter, Inc.K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K241165Atellica® IM High-Sensitivity Troponin I (TnIH)Siemens Healthcare 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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