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510(k) K133851

ALERE PBP2A SA/CONS CULTURE COLONY TEST by Alere Scarborough, Inc. — Product Code MYI

K133851 is an FDA 510(k) premarket notification submitted by Alere Scarborough, Inc. for the device "ALERE PBP2A SA/CONS CULTURE COLONY TEST". The FDA issued a decision of Substantially Equivalent on September 3, 2014. The device falls under product code MYI (System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies), a Class II device regulated under 21 CFR 866.1640. Alere Scarborough, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2014
Date Received
December 19, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

Other clearances by Alere Scarborough, Inc.

  • DEN180014 — WOUNDCHEK Bacterial Status (December 2, 2019)
  • K190204 — ID NOW Influenza A & B 2 (March 18, 2019)
  • K181853 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader (August 8, 2018)
  • K173653 — Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit (May 2, 2018)
  • K173932 — Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 (January 26, 2018)
  • K173502 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A (December 13, 2017)
  • K171792 — Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control S (September 29, 2017)
  • K162642 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A (April 10, 2017)
  • K163266 — Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instr (December 21, 2016)
  • K161375 — Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit (August 18, 2016)

Other clearances for product code MYI

  • K140619 — MECA XPRESSFISH (October 10, 2014)
  • K121905 — ALERE PBP2A TEST (July 26, 2012)
  • K090301 — BINAXNOW PBP2A TEST, MODEL 890-000 (April 14, 2010)
  • K091766 — CLEARVIEW EXACT PBP2A TEST, MODEL 891-000 (February 24, 2010)
  • K062864 — MASTALEX -MRSA, MODEL RST501 (October 18, 2006)
  • K011710 — OXOID PBP2 1 LATEX AGGLUTINATION TEST (April 2, 2002)
  • K011400 — MRSA-SCREEN (March 27, 2002)
  • K010858 — VELOGENE GENOMIC IDENTIFICATION ASSAY FOR MRSA WITH ONE-STEP DETECTION (May 24, 2001)
  • K990640 — VELOGENE RAPID MRSA IDENTIFICATION ASSAY (July 9, 1999)

FDA data resources