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Mainline Technology, Inc.

9 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregn recall (Z-1018-2010)Mainline Technology, Inc.2010-03-08
Mainline Confirms Strep A, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3030-20 a recall (Z-0525-2009)Mainline Technology, Inc.2009-01-15
Mainline Confirms Strep A DOTS, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 4040 recall (Z-0526-2009)Mainline Technology, Inc.2009-01-15
Mainline Confirms III Serum/Urine control set, Mainline Technologies, Inc., Ann Arbor, MI; recall (Z-0527-2009)Mainline Technology, Inc.2009-01-15
Mainline hCG Accuracy Check, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3c1001. recall (Z-0528-2009)Mainline Technology, Inc.2009-01-15
Mainline Confirms hCG Serum/Urine III, Mainline Technologies, Inc., Ann Arbor, MI; Catalog recall (Z-0529-2009)Mainline Technology, Inc.2009-01-15
f.y.i. hCG Urine one-step pregnancy test, Carmel Diagnostics, LLC, Naples, FL; Catalog # 4 recall (Z-0530-2009)Mainline Technology, Inc.2009-01-15
Mainline Confirms hCG urine pregnancy test, Mainline Technologies, Inc., Ann Arbor, MI; Ca recall (Z-0531-2009)Mainline Technology, Inc.2009-01-15
Mainline Confirms Strep A, Group A Streptococcus; A rapid one-step visual test for the det recall (Z-2427-2008)Mainline Technology, Inc.2008-09-22

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Every clearance here is in the API, with alerts when new ones post.