Data / Medical devices / United States / JAS Diagnostics/Drew Scientific

JAS Diagnostics/Drew Scientific: FDA-registered device maker in Plantation, FL, United States, 5 510(k) clearances

Name: JAS Diagnostics/Drew Scientific FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

JAS Diagnostics/Drew Scientific is registered with the FDA (registration 1064608) in Plantation, FL, United States. It lists 9 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 11, 2007. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1064608
FEI number: 3003071743
Address: 6600 NW 14th Street BAY 12, Plantation, FL, United States, 33313
Owner or operator: JAS Diagnostics/Drew Scientific (9042128)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: January 18, 2013
Registered through: 2026
Brand names listed: D3 Hematology Analyzer Model D3, Differential Lyse (20L); Drew 3 Reagent Pac; Drew-3 Lytic Reagent; EX-Lyse; EX-PAC2, Drew-3 Enzymatic Cleaner; E-Z Clean, EX-Ezyme, Drew Hematology Clean, Drew-3 Hematology Diluent; EX-ISO Hematology Diluent, EX-CAL Hematology Calibrator, EX-Trol Controls (Low, Normal, High), EX-Trol Plus Controls (Low, Normal, High)

Devices it lists

Device	Product code	Class	Role	Source
Calibrator For Cell Indices	KRX	2	Repackager or relabeler	accessdata.fda.gov
Calibrator For Hemoglobin And Hematocrit Measurement	KRZ	2	Repackager or relabeler	accessdata.fda.gov
Calibrator For Platelet Counting	KRY	2	Repackager or relabeler	accessdata.fda.gov
Calibrator For Red-Cell And White-Cell Counting	KSA	2	Repackager or relabeler	accessdata.fda.gov
Counter, Differential Cell	GKZ	2	Specification developer	accessdata.fda.gov
Detergent	JCB	1	Manufacturer	accessdata.fda.gov
Diluent, Blood Cell	GIF	1	Manufacturer	accessdata.fda.gov
Mixture, Hematology Quality Control	JPK	2	Repackager or relabeler	accessdata.fda.gov
Products, Red-Cell Lysing Products	GGK	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 11, 2007	K071562	D3 HEMATOLOGY ANALYZER, MODEL D3	GKZ	Substantially Equivalent	Drew Scientific, Inc.	accessdata.fda.gov
July 10, 2006	K061511	R&D CBC-3D + CRP HEMATOLOGY CONTROL	JPK	Substantially Equivalent	R&D Systems, Inc.	accessdata.fda.gov
January 16, 2001	K003991	CD-CAL PLUS CALIBRATOR	KRX	Substantially Equivalent	R&D Systems, Inc.	accessdata.fda.gov
January 12, 2001	K003874	CBC-4K HEMATOLOGY CONTROL	JPK	Substantially Equivalent	R&D Systems, Inc.	accessdata.fda.gov
September 20, 1995	K952720	AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II	JPK	Substantially Equivalent	Aalto Scientific, Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 21, 2017	77464	Class II	Terminated	Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.	May result in elevated platelet backgrounds during routine startup/background checks.	accessdata.fda.gov
March 10, 2016	73650	Class II	Terminated	Drew Scientific Inc. Drew3-PAC. This D3 Reagent Pack includes: diluent reagent 5L, enzymatic cleaner 750 mL, and a lysing reagent 125 mL.	The reagent pack may result in elevated platelet background during Drew3 Hematology Analyzer routine check.	accessdata.fda.gov
October 23, 2014	69622	Class II	Terminated	Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.	Product is not performing according to specifications. Control 2 does not consistently recover within its assigned range.	accessdata.fda.gov
April 7, 2014	68343	Class II	Terminated	Glucose Hexokinase Liquid Reagent For the in vitro quantitative determination of Glucose in serum.	JAS Diagnostics, Inc. of Miami Lakes, FL is recalling their Glucose Hexokinase reagent due to certain lots not performing according to their specifications.	accessdata.fda.gov
September 20, 2006	36728	Not yet classified	Terminated	Bayer Advia 70 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.	System has given inaccurate readings when running samples that trigger an extra rinse due to very high WBC, RBC or Platlet counts.	accessdata.fda.gov
August 24, 2006	36706	Not yet classified	Terminated	Bayer Advia 70 Hematology Analyzer, manufactured by Drew Scientific, Inc., Dallas, TX.	Flags and alerts on the user interface will not automatically transfering to the LIS.	accessdata.fda.gov

Compare with other makers

Updated December 11, 2007. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.