FDA 510(k) K992140, PICCOLO METLYTE 7 REAGENT DISC, by Abaxis, Inc.
FDA 510(k) K992140, PICCOLO METLYTE 7 REAGENT DISC, by Abaxis, Inc.
Device Classification Name: Atp And Creatine Kinase (Enzymatic), Creatine
510(k) Number: K992140
Device Name: PICCOLO METLYTE 7 REAGENT DISC
Applicant: Abaxis, Inc.
Regulation Number: 862.1210
Classification Product Code: JLB
Date Received: 06/24/1999
Decision Date: 08/26/1999
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
510k Review Panel: Clinical Chemistry
Total number of pages: 977
Fully redacted pages: 278
Content pages: 699
Couldn't load pickup availability
PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.
View full details