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FDA 510(k)

METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK

K-Number: K042336 · 2004-10-14

ApplicantBio-Rad Laboratories, Inc.
Decision Date2004-10-14
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories, Inc.. It received FDA 510(k) clearance on 2004-10-14 under 510(k) number K042336. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK?

METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK is a medical device that received FDA 510(k) clearance on 2004-10-14. The listed applicant is Bio-Rad Laboratories, Inc.. The 510(k) number is K042336.

When did METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK receive FDA 510(k) clearance?

METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK received FDA 510(k) clearance on 2004-10-14, under 510(k) number K042336.

Who is the listed applicant for METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK?

The FDA 510(k) record lists Bio-Rad Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK?

The FDA product code for METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK is JPK.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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