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FDA 510(k)

PICCOLO PHOSPHORUS TEST SYSTEM

K-Number: K022312 · 2002-09-05

ApplicantAbaxis, Inc.
Decision Date2002-09-05
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PICCOLO PHOSPHORUS 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 2002-09-05 under 510(k) number K022312. The device is classified under product code CEO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PICCOLO PHOSPHORUS TEST SYSTEM?

PICCOLO PHOSPHORUS TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2002-09-05. The listed applicant is Abaxis, Inc.. The 510(k) number is K022312.

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

PICCOLO PHOSPHORUS TEST SYSTEM received FDA 510(k) clearance on 2002-09-05, under 510(k) number K022312.

Who is the listed applicant for PICCOLO PHOSPHORUS 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 PHOSPHORUS TEST SYSTEM?

The FDA product code for PICCOLO PHOSPHORUS TEST SYSTEM is CEO.

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Other records listing Abaxis, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200865Piccolo Potassium Test SystemK130113PICCOLO LACTATE TEST SYSTEMK130200PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEMK120664PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEMK120662PICCOLO HDL-CAPILLARY TEST SYSTEMK091052PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM

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Related Devices (Code: CEO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K100263ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTSSeppim S.A.S.K072141S40 CLINICAL ANALYZER, S TEST IP, S TEST UAAlfa Wassermann Diagnostic Technologies, Inc.K041643SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENTBeckman Coulter, Inc.K030015ATAC PAK PHOSPHORUS REAGENTElan DiagnosticsK013095WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311Wiener Laboratories SaicK003912PHOSPHORUS REAGENTJas Diagnostics, Inc.

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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