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FDA 510(k)

ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5

K-Number: K984626 · 1999-01-29

ApplicantBio-Rad
Decision Date1999-01-29
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5 is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 1999-01-29 under 510(k) number K984626. 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 B12 MASTERCHEK, MODEL # 6C09-O5?

ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5 is a medical device that received FDA 510(k) clearance on 1999-01-29. The listed applicant is Bio-Rad. The 510(k) number is K984626.

When did ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5 receive FDA 510(k) clearance?

ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5 received FDA 510(k) clearance on 1999-01-29, under 510(k) number K984626.

Who is the listed applicant for ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5?

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 B12 MASTERCHEK, MODEL # 6C09-O5?

The FDA product code for ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5 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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