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FDA 510(k)

CONTREX PLUS LOW CONTROL SOLUTION

K-Number: K100747 · 2010-04-14

ApplicantApex BioTechnology Corp.
Decision Date2010-04-14
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CONTREX PLUS LOW CONTROL SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Apex BioTechnology Corp.. It received FDA 510(k) clearance on 2010-04-14 under 510(k) number K100747. 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 CONTREX PLUS LOW CONTROL SOLUTION?

CONTREX PLUS LOW CONTROL SOLUTION is a medical device that received FDA 510(k) clearance on 2010-04-14. The listed applicant is Apex BioTechnology Corp.. The 510(k) number is K100747.

When did CONTREX PLUS LOW CONTROL SOLUTION receive FDA 510(k) clearance?

CONTREX PLUS LOW CONTROL SOLUTION received FDA 510(k) clearance on 2010-04-14, under 510(k) number K100747.

Who is the listed applicant for CONTREX PLUS LOW CONTROL SOLUTION?

The FDA 510(k) record lists Apex BioTechnology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CONTREX PLUS LOW CONTROL SOLUTION?

The FDA product code for CONTREX PLUS LOW CONTROL SOLUTION 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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