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FDA 510(k)

ACCESS OSTASE QC

K-Number: K994277 · 2000-01-14

ApplicantBeckman Coulter, Inc.
Decision Date2000-01-14
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCESS OSTASE QC is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2000-01-14 under 510(k) number K994277. 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 ACCESS OSTASE QC?

ACCESS OSTASE QC is a medical device that received FDA 510(k) clearance on 2000-01-14. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K994277.

When did ACCESS OSTASE QC receive FDA 510(k) clearance?

ACCESS OSTASE QC received FDA 510(k) clearance on 2000-01-14, under 510(k) number K994277.

Who is the listed applicant for ACCESS OSTASE QC?

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

What is the FDA product code for ACCESS OSTASE QC?

The FDA product code for ACCESS OSTASE QC 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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