Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PICCOLO METLYTE 7 REAGENT DISC

K-Number: K992140 · 1999-08-26

ApplicantAbaxis, Inc.
Decision Date1999-08-26
Product CodeJLB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PICCOLO METLYTE 7 REAGENT DISC is the device name listed in this FDA 510(k) record. The listed applicant is Abaxis, Inc.. It received FDA 510(k) clearance on 1999-08-26 under 510(k) number K992140. The device is classified under product code JLB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PICCOLO METLYTE 7 REAGENT DISC?

PICCOLO METLYTE 7 REAGENT DISC is a medical device that received FDA 510(k) clearance on 1999-08-26. The listed applicant is Abaxis, Inc.. The 510(k) number is K992140.

When did PICCOLO METLYTE 7 REAGENT DISC receive FDA 510(k) clearance?

PICCOLO METLYTE 7 REAGENT DISC received FDA 510(k) clearance on 1999-08-26, under 510(k) number K992140.

Who is the listed applicant for PICCOLO METLYTE 7 REAGENT DISC?

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 METLYTE 7 REAGENT DISC?

The FDA product code for PICCOLO METLYTE 7 REAGENT DISC is JLB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 20 devices →

Related Devices (Code: JLB)

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.

K971817OLYMPUS CK-MB REAGENTOlympus America, Inc.K782156UNITEST CREATINE KINASEBoehringer Mannheim Corp.

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.

↑