Data / Medical devices / United States / Service Graphics, Inc.

Service Graphics, Inc.: FDA-registered device maker in Indianapolis, IN, United States, 6 510(k) clearances

Name: Service Graphics, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Service Graphics, Inc. is registered with the FDA (registration 3001452053) in Indianapolis, IN, United States. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 2, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3001452053
Address: 8350 Allison Ave., Indianapolis, IN, United States, 46268
Owner or operator: SERVICE GRAPHICS, INC. (9052909)
Roles: Repackager or relabeler
First device listed: June 22, 2011
Registered through: 2026
Brand names listed: ACCU-CHEK Aviva Plus Test Strips, ACCU-CHEK Aviva Plus, ACCU-CHEK Nano, ACCU-CHEK Compact Plus, ACCU-CHEK Aviva Plus, ACCU-CHEK Nano, ACCU-CHEK SmartView Test Strips, ACCU-CHEK Softclix, Blood Collection Vial, Buccal Collection Vial, Saliva Collection Vial

Devices it lists

Device	Product code	Class	Role	Source
Dna Specimen Collection, Saliva	OYJ	2	Repackager or relabeler	accessdata.fda.gov
Glucose Dehydrogenase, Glucose	LFR	2	Repackager or relabeler	accessdata.fda.gov
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1	Repackager or relabeler	accessdata.fda.gov
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	FMK	2	Repackager or relabeler	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Repackager or relabeler	accessdata.fda.gov
Tubes, Vacuum Sample, With Anticoagulant	GIM	2	Repackager or relabeler	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Repackager or relabeler	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
February 2, 2024	K231373	BD Vacutainer® K2 EDTA Blood Collection Tubes	JKA	Substantially Equivalent	Becton, Dickinson and Company	accessdata.fda.gov
October 27, 2022	K212745	ORAcollect®Dx	OYJ	Substantially Equivalent	DNA Genotek, Inc.	accessdata.fda.gov
July 15, 2008	K081389	ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM	NBW	Substantially Equivalent	Roche Diagnostics	accessdata.fda.gov
August 11, 2006	K060620	ACCU-CHEK AVIVA TEST STRIPS	NBW	Substantially Equivalent	Roche Diagnostics Corp.	accessdata.fda.gov
April 27, 2005	K043474	ACCU-CHEK AVIVA SYSTEM	LFR	Substantially Equivalent	Roche Diagnostics Corp.	accessdata.fda.gov
February 10, 1994	K931258	SOFTTOUCH II LANCET DEVICE	FMK	Substantially Equivalent	Boehringer Mannheim Corp.	accessdata.fda.gov

Compare with other makers

Updated February 2, 2024. 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.