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FDA 510(k)

ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05

K-Number: K983578 · 1998-11-12

ApplicantBio-Rad
Decision Date1998-11-12
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1998-11-12 under 510(k) number K983578. 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 TESTOSTERONE MASTERCHECK, MODEL 6C28-05?

ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05 is a medical device that received FDA 510(k) clearance on 1998-11-12. The listed applicant is Bio-Rad. The 510(k) number is K983578.

When did ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05 receive FDA 510(k) clearance?

ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05 received FDA 510(k) clearance on 1998-11-12, under 510(k) number K983578.

Who is the listed applicant for ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05?

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 TESTOSTERONE MASTERCHECK, MODEL 6C28-05?

The FDA product code for ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05 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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