ClearanceBrief
Company ยท US

Mainline Technology, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2003. Name variants (Inc, Corp, punctuation) are merged.

1510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
JHIVisual, Pregnancy Hcg, Prescription Use8
GTYAntigens, All Groups, Streptococcus Spp.1
LCXKit, Test, Pregnancy, Hcg, Over The Counter1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jul 1, 2003K031445MAINLINE MAXIE HCG URINE PREGNANCY TEST
Mainline Technology, Inc.
JHI

Latest recalls

DateFirm and productCodeLinked 510(k)
Mar 8, 2010Mainline Technology, Inc.
Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregnancy test.
Terminated		 LCXNone listed
Jan 15, 2009Mainline Technology, Inc.
Mainline Confirms hCG urine pregnancy test, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 6008C.
Terminated		 JHINone listed
Jan 15, 2009Mainline Technology, Inc.
f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL; Catalog # 43065.
Terminated		 JHINone listed
Jan 15, 2009Mainline Technology, Inc.
Mainline Confirms hCG Serum/Urine III, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3029-25.
Terminated		 JHINone listed
Jan 15, 2009Mainline Technology, Inc.
Mainline hCG Accuracy Check, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3c1001.
Terminated		 JHINone listed
Jan 15, 2009Mainline Technology, Inc.
Mainline Confirms III Serum/Urine control set, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3029-CTR.
Terminated		 JHINone listed
Jan 15, 2009Mainline Technology, Inc.
Mainline Confirms Strep A DOTS, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 4040.
Terminated		 JHINone listed
Jan 15, 2009Mainline Technology, Inc.
Mainline Confirms Strep A, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3030-20 and 3030-40.
Terminated		 JHINone listed
Sep 22, 2008Mainline Technology, Inc.
Mainline Confirms Strep A, Group A Streptococcus; A rapid one-step visual test for the detection of group A streptococcal antigen directly from throat swabs, Mainline Technology, Inc., Ann Arbor, MI;
Terminated		 GTYNone listed
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