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FDA 510(k)

PICCOLO(TM)

K-Number: K942782 · 1995-03-13

ApplicantAbaxis, Inc.
Decision Date1995-03-13
Product CodeJJG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PICCOLO(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Abaxis, Inc.. It received FDA 510(k) clearance on 1995-03-13 under 510(k) number K942782. The device is classified under product code JJG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PICCOLO(TM)?

PICCOLO(TM) is a medical device that received FDA 510(k) clearance on 1995-03-13. The listed applicant is Abaxis, Inc.. The 510(k) number is K942782.

When did PICCOLO(TM) receive FDA 510(k) clearance?

PICCOLO(TM) received FDA 510(k) clearance on 1995-03-13, under 510(k) number K942782.

Who is the listed applicant for PICCOLO(TM)?

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(TM)?

The FDA product code for PICCOLO(TM) is JJG.

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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: JJG)

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.

K972409AG CHEMISTRY ANALYZER SYSTEMLandmark Scientific, Inc.K934592EPOC 2000 POINT-OF-CARE ANALYZER AND EPOC 5-CHEMISTRY REAGENT ROTORAbaxis, Inc.K920942OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZEROlympus Corp.K910222COBAS ALPHARoche Diagnostic Systems, Inc.K903626BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISABeckman Instruments, Inc.K893854COBAS FARA II CENTRIFUGAL ANALYZERRoche 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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