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FDA 510(k)

ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05

K-Number: K984327 · 1998-12-22

ApplicantBio-Rad
Decision Date1998-12-22
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1998-12-22 under 510(k) number K984327. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05?

ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05 is a medical device that received FDA 510(k) clearance on 1998-12-22. The listed applicant is Bio-Rad. The 510(k) number is K984327.

When did ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05 receive FDA 510(k) clearance?

ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05 received FDA 510(k) clearance on 1998-12-22, under 510(k) number K984327.

Who is the listed applicant for ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05?

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

What is the FDA product code for ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05?

The FDA product code for ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05 is JJX.

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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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