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510(k) K873832

REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801 by In Vitro Diagnostics, Inc. — Product Code KRZ

K873832 is an FDA 510(k) premarket notification submitted by In Vitro Diagnostics, Inc. for the device "REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801". The FDA issued a decision of Substantially Equivalent on November 23, 1987. The device falls under product code KRZ (Calibrator For Hemoglobin And Hematocrit Measurement), a Class II device regulated under 21 CFR 864.8165. In Vitro Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1987
Date Received
September 21, 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 In Vitro Diagnostics, Inc.

  • K896867 — THYROID STIMULATING HORMONE-EIA-XT (February 23, 1990)
  • K896866 — LUTEINIZING HORMONE-EIA-XT (February 13, 1990)
  • K896863 — DIGOXIN-EIA-XT (February 13, 1990)
  • K896865 — VITRO T4-EIA-XT (January 30, 1990)
  • K896925 — T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KIT (January 18, 1990)
  • K896864 — FOLLICLE STIMULATING HORMONE-EIA-XT (January 11, 1990)
  • K871187 — LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084 (May 28, 1987)
  • K871185 — LITHIUM INTERNAL STANDARD 1 MEQ/L #60085 (May 28, 1987)
  • K871184 — FLAME PHOTOMETER STANDARD #60083 160 NA/8K (May 28, 1987)
  • K871186 — CESIUM DILUENT 1.5 MMOL CS/L #60087 (May 28, 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