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510(k) K020616

BAYER RAPIDPOINT 405 SYSTEM by Bayer Diagnostics Corp. — Product Code GKR

K020616 is an FDA 510(k) premarket notification submitted by Bayer Diagnostics Corp. for the device "BAYER RAPIDPOINT 405 SYSTEM". The FDA issued a decision of Substantially Equivalent on July 17, 2002. The device falls under product code GKR (System, Hemoglobin, Automated), a Class II device regulated under 21 CFR 864.5620. Bayer Diagnostics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 2002
Date Received
February 25, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Hemoglobin, Automated
Device Class
Class II
Regulation Number
864.5620
Review Panel
HE
Submission Type

Other clearances by Bayer Diagnostics Corp.

  • K033379 — BAYER SPECIAL CHEMISTRY CONTROLS (December 19, 2003)
  • K033380 — BAYER SPECIAL CHEMISTRY CALIBRATORS (December 16, 2003)
  • K033007 — BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM (November 14, 2003)
  • K031857 — ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY (September 4, 2003)
  • K022096 — URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (March 18, 2003)
  • K030452 — BAYER LIGAND PLUS 1, 2, 3 CONTROLS (March 3, 2003)
  • K023840 — ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 (January 7, 2003)
  • K023841 — AMMONIA ASSAY FOR THE ADVIA 1650 (December 24, 2002)
  • K022177 — PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (December 17, 2002)
  • K022329 — CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM (November 27, 2002)

Other clearances for product code GKR

  • K201217 — HemoCue Hb 301 System (August 4, 2020)
  • K200909 — Hemo Control (optional Add Pack Hemo Control DM) (June 12, 2020)
  • K181751 — HemoCue Hb 801 System (February 1, 2019)
  • K182298 — hemochroma PLUS System (November 16, 2018)
  • K172173 — DiaSpect Tm, DiaSpect Tm Cuvettes (April 6, 2018)
  • K163465 — hemochroma PLUS System (September 8, 2017)
  • K122553 — MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM (August 5, 2013)
  • K121752 — AVIE TOTAL HB TEST SYSTEM (January 7, 2013)
  • K110393 — EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM; EKF-DIAGNOSTIC HEMOG (March 4, 2011)
  • K090093 — STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM (June 10, 2009)

FDA data resources