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510(k) K871283

CYANMETHEMOGLOBIN STANDARD by U. S. Diagnostics, Inc. — Product Code KRZ

K871283 is an FDA 510(k) premarket notification submitted by U. S. Diagnostics, Inc. for the device "CYANMETHEMOGLOBIN STANDARD". The FDA issued a decision of Substantially Equivalent on April 15, 1987. The device falls under product code KRZ (Calibrator For Hemoglobin And Hematocrit Measurement), a Class II device regulated under 21 CFR 864.8165. U. S. Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 1987
Date Received
March 31, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator For Hemoglobin And Hematocrit Measurement
Device Class
Class II
Regulation Number
864.8165
Review Panel
HE
Submission Type

Other clearances by U. S. Diagnostics, Inc.

  • K110435 — EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM (September 21, 2011)
  • K082201 — G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A (February 20, 2009)
  • K061431 — EASYGLUCO, MODEL IGM-0002 G2 (January 12, 2007)
  • K051651 — G4, MODEL IGM-0004 (April 14, 2006)
  • K870685 — COAGULATION CONTROL, LEVEL I (April 20, 1987)
  • K870596 — PROTHROMBIN TIME TEST (April 20, 1987)
  • K870687 — COAGULATION CONTROL, LEVEL III (April 20, 1987)
  • K870686 — COAGULATION CONTROL, LEVEL II (April 20, 1987)
  • K870737 — U.S. DIAGNOSTICS LIQUID LD ISOENZYME CONTROL (April 13, 1987)
  • K870738 — U.S. DIAGNOSTICS LIQUID CK ISOENZYME CONTROL (April 13, 1987)

Other clearances for product code KRZ

  • K052101 — C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C (August 26, 2005)
  • K041130 — CDS HEMATOLOGY CALIBRATOR (CDS CAL) (June 10, 2004)
  • K962864 — THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS (December 18, 1996)
  • K951071 — ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS (July 24, 1995)
  • K902892 — CELL-DYN CALIBRATOR (September 10, 1990)
  • K896921 — RAICHEM TM HEMOGLOBIN CALIBRATOR (January 25, 1990)
  • K893984 — HGB-CAL SET/MULTIPLE (August 15, 1989)
  • K883703 — MSI-CAL 7 (November 22, 1988)
  • K883850 — MSI-CAL 16 (November 22, 1988)
  • K883851 — MSI-CAL 8 (November 22, 1988)

FDA data resources