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FDA 510(k)

HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51

K-Number: K980770 · 1998-04-21

ApplicantDiagnostic Chemicals , Ltd.
Decision Date1998-04-21
Product CodeLBR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 1998-04-21 under 510(k) number K980770. The device is classified under product code LBR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51?

HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 is a medical device that received FDA 510(k) clearance on 1998-04-21. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K980770.

When did HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 receive FDA 510(k) clearance?

HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 received FDA 510(k) clearance on 1998-04-21, under 510(k) number K980770.

Who is the listed applicant for HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51?

The FDA 510(k) record lists Diagnostic Chemicals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51?

The FDA product code for HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51 is LBR.

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Related Devices (Code: LBR)

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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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