Home / 510(k) Clearances / K791287

510(k) K791287

MEDICOR QUALITY CONTROL BUFFER by Medicor USA , Ltd. — Product Code JJS

K791287 is an FDA 510(k) premarket notification submitted by Medicor USA , Ltd. for the device "MEDICOR QUALITY CONTROL BUFFER". The FDA issued a decision of Substantially Equivalent on August 16, 1979. The device falls under product code JJS (Controls For Blood-Gases, (Assayed And Unassayed)), a Class I device regulated under 21 CFR 862.1660. Medicor USA , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1979
Date Received
July 10, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controls For Blood-Gases, (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

Other clearances by Medicor USA , Ltd.

  • K861994 — MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM (July 18, 1986)
  • K861995 — MODEL RS-3 RADIOGRAPHIC STAND (June 19, 1986)
  • K860025 — MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR (May 7, 1986)
  • K850761 — MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C (September 19, 1985)
  • K851358 — MODEL BION 2/TYPE 90 ROOM IONIZER (July 1, 1985)
  • K851094 — MODEL BION 1/TYPE 1084T CAR IONIZER (June 19, 1985)
  • K843335 — FLOOR MOUNTED X-RAY TUBESTAND (November 27, 1984)
  • K840227 — UROLIX-3 UROLOGICAL TABLE (March 23, 1984)
  • K840225 — C-ARM CEILING CRANE FT-2 (March 22, 1984)
  • K840226 — MOTOR TILTED EXAM. TABLE UV-56 (March 16, 1984)

Other clearances for product code JJS

  • K152553 — CueSee Hypoxic (April 22, 2016)
  • K150226 — Hematocrit and Metabolite QUALICHECK (May 13, 2015)
  • K130415 — HIGH METABOLITE QUALICHECK (March 26, 2013)
  • K130236 — RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL (March 15, 2013)
  • K033063 — MISSION CONTROLS (December 12, 2003)
  • K022529 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, A (August 15, 2002)
  • K022525 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 (August 15, 2002)
  • K003242 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 (November 30, 2000)
  • K003239 — LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 (November 30, 2000)
  • K002865 — LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 (September 25, 2000)

FDA data resources