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FDA 510(k)

PICCOLO SODIUM TEST SYSTEM

K-Number: K993211 · 1999-10-25

ApplicantAbaxis, Inc.
Decision Date1999-10-25
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PICCOLO SODIUM TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abaxis, Inc.. It received FDA 510(k) clearance on 1999-10-25 under 510(k) number K993211. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PICCOLO SODIUM TEST SYSTEM?

PICCOLO SODIUM TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1999-10-25. The listed applicant is Abaxis, Inc.. The 510(k) number is K993211.

When did PICCOLO SODIUM TEST SYSTEM receive FDA 510(k) clearance?

PICCOLO SODIUM TEST SYSTEM received FDA 510(k) clearance on 1999-10-25, under 510(k) number K993211.

Who is the listed applicant for PICCOLO SODIUM TEST SYSTEM?

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

What is the FDA product code for PICCOLO SODIUM TEST SYSTEM?

The FDA product code for PICCOLO SODIUM TEST SYSTEM is JGS.

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Other records listing Abaxis, Inc. as applicant

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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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