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FDA 510(k)

ACCESS HYBRITECH FREE PSA QC, MODEL 37219

K-Number: K993210 · 2000-01-05

ApplicantBeckman Coulter, Inc.
Decision Date2000-01-05
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCESS HYBRITECH FREE PSA QC, MODEL 37219 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 2000-01-05 under 510(k) number K993210. 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 HYBRITECH FREE PSA QC, MODEL 37219?

ACCESS HYBRITECH FREE PSA QC, MODEL 37219 is a medical device that received FDA 510(k) clearance on 2000-01-05. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K993210.

When did ACCESS HYBRITECH FREE PSA QC, MODEL 37219 receive FDA 510(k) clearance?

ACCESS HYBRITECH FREE PSA QC, MODEL 37219 received FDA 510(k) clearance on 2000-01-05, under 510(k) number K993210.

Who is the listed applicant for ACCESS HYBRITECH FREE PSA QC, MODEL 37219?

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 HYBRITECH FREE PSA QC, MODEL 37219?

The FDA product code for ACCESS HYBRITECH FREE PSA QC, MODEL 37219 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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