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FDA 510(k)

ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

K-Number: K974075 · 1997-11-10

ApplicantBeckman Instruments, Inc.
Decision Date1997-11-10
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Instruments, Inc.. It received FDA 510(k) clearance on 1997-11-10 under 510(k) number K974075. 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 ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER?

ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER is a medical device that received FDA 510(k) clearance on 1997-11-10. The listed applicant is Beckman Instruments, Inc.. The 510(k) number is K974075.

When did ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER receive FDA 510(k) clearance?

ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER received FDA 510(k) clearance on 1997-11-10, under 510(k) number K974075.

Who is the listed applicant for ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER?

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

What is the FDA product code for ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER?

The FDA product code for ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER is MMI.

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Other records listing Beckman Instruments, 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.

K973448ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERK981403IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENTK981354ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211K980173ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505K974816ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229

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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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