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FDA 510(k)

PICCOLO HDL-CAPILLARY TEST SYSTEM

K-Number: K120662 · 2012-04-24

ApplicantAbaxis, Inc.
Decision Date2012-04-24
Product CodeJHM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PICCOLO HDL-CAPILLARY 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 2012-04-24 under 510(k) number K120662. The device is classified under product code JHM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PICCOLO HDL-CAPILLARY TEST SYSTEM?

PICCOLO HDL-CAPILLARY TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2012-04-24. The listed applicant is Abaxis, Inc.. The 510(k) number is K120662.

When did PICCOLO HDL-CAPILLARY TEST SYSTEM receive FDA 510(k) clearance?

PICCOLO HDL-CAPILLARY TEST SYSTEM received FDA 510(k) clearance on 2012-04-24, under 510(k) number K120662.

Who is the listed applicant for PICCOLO HDL-CAPILLARY 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 HDL-CAPILLARY TEST SYSTEM?

The FDA product code for PICCOLO HDL-CAPILLARY TEST SYSTEM is JHM.

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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 SYSTEMK091052PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEMK091910PICCOLO MAGNESIUM TEST SYSTEM

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Related Devices (Code: JHM)

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.

K081300DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGESiemens Healthcare DiagnosticsK073072DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48BDade Behring, Inc.K032798DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48ADade Behring, Inc.K022519LDL CHOLESTEROL (AUTOMATED)Jas Diagnostics, Inc.K983849DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGEDade Behring, Inc.K902935ROCHE COBAS READY HDL CHOLESTEROL REAGENTRoche Diagnostic Systems, 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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