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510(k) K781361

HEMOGLOBINOMETER MODEL 720 B by Innovative Medical Systems, Inc. — Product Code GKR

K781361 is an FDA 510(k) premarket notification submitted by Innovative Medical Systems, Inc. for the device "HEMOGLOBINOMETER MODEL 720 B". The FDA issued a decision of Substantially Equivalent on September 14, 1978. The device falls under product code GKR (System, Hemoglobin, Automated), a Class II device regulated under 21 CFR 864.5620. Innovative Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1978
Date Received
August 7, 1978
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 Innovative Medical Systems, Inc.

  • K973035 — VIOLA II DENTAL CAMERA SYSTEM (September 24, 1997)
  • K951469 — BAZOOKA SYSTEM (June 28, 1995)
  • K933184 — POSITIVE AIRWAY PRESSURE SYSTEM (November 28, 1994)
  • K924590 — MICROWAVE AUTOMATED TISSUE PROCESSOR (December 29, 1992)
  • K922081 — LABOTECH AUTOMATED MICROTITER ANALYZER (September 2, 1992)
  • K921005 — AUTOLOADER (April 29, 1992)
  • K915457 — PHACO 20/20 SYSTEM I (February 24, 1992)
  • K915456 — PHACO 3000 LINEAR (February 12, 1992)
  • K883599 — LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) (September 2, 1988)
  • K880745 — LX-100 SLIDE STAINER (April 27, 1988)

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