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FDA 510(k), K163015, Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
FDA 510(k), K163015, Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
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510(K) Number: K163015
Device Name: Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
Manufacturer: BIO-RAD LABORATORIES
Device Classification Name: multi-analyte controls, all kinds (assayed)
Regulation Number: 862.1660
Classification Product Code: JJY
Date Received: 10/28/2016
Decision Date: 01/10/2017
Regulation Medical Specialty: Clinical Chemistry
Device Name: Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
Manufacturer: BIO-RAD LABORATORIES
Device Classification Name: multi-analyte controls, all kinds (assayed)
Regulation Number: 862.1660
Classification Product Code: JJY
Date Received: 10/28/2016
Decision Date: 01/10/2017
Regulation Medical Specialty: Clinical Chemistry
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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