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510(k) K024360

INSTANT-VIEW H. PYLORI ONE STEP RAPID TEST by Alfa Scientific Designs, Inc. — Product Code LYR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2003
Date Received
December 30, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Helicobacter Pylori
Device Class
Class I
Regulation Number
866.3110
Review Panel
MI
Submission Type

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  • K131645 — INSTANT-VIEW MULTI-DRUG OF ABUSE URINE TEST (CUP, PANEL CASSETTE) (October 7, 2013)
  • K100051 — INSTANT-VIEW MILTI-DRUG OF ABUSE URINE TEST (PANEL, CUP), INSTANT-VERDICT MULTI- (July 6, 2010)
  • K070660 — INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST (June 21, 2007)
  • K063545 — MULTI-DRUG OF ABUSE URINE TEST,URINE CUP TEST, AMPHETAMINE URINE TEST(CASSETTE, (May 7, 2007)
  • K060527 — INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST; INSTANT (July 25, 2006)
  • K042227 — INSTANT-VIEW TROPONIN I TEST (November 19, 2004)
  • K022693 — INSTANT-VIEW TCA URINE TEST (December 9, 2002)

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  • K181464 — LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set (August 31, 2018)
  • K181379 — H. PYLORI QUIK CHEK (August 21, 2018)
  • K181400 — H. PYLORI CHEK™ (August 21, 2018)
  • K161139 — LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set (July 22, 2016)
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