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510(k) K771314

GLUCOSE REAGENT (O-TOLUIDINE) by Mallinckrodt Critical Care — Product Code CGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1977
Date Received
July 18, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthotoluidine, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Mallinckrodt Critical Care

  • K880343 — BURNEY GALLBLADDER CATHETER KIT (May 1, 1989)
  • K874605 — HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (February 2, 1988)
  • K874514 — HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE (January 29, 1988)
  • K874568 — HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR (January 6, 1988)
  • K874404 — HI-LO TEMP(R) SKIN TEMPERATURE SENSOR (November 6, 1987)
  • K873461 — LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) (November 6, 1987)
  • K873833 — THERMOCOUPLE ADAPTER (November 3, 1987)
  • K873004 — GUIDING CATHETER (September 15, 1987)
  • K871204 — CUFFED TRACHEAL TUBE (MULTIPLE) (April 21, 1987)
  • K862666 — UNCUFFED LASER RESISTEANT TRACHEAL TUBE(TENTATIVE) (August 1, 1986)

Other clearances for product code CGE

  • K890335 — SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. (February 17, 1989)
  • K855185 — GLUCOSE REAGENT SET (January 22, 1986)
  • K850930 — GLUCOSE (June 10, 1985)
  • K841054 — DIRECT GLUCOSE REAGENT SET (May 1, 1984)
  • K821198 — DIRECT GLUCOSE REAGENT SET (July 13, 1982)
  • K811883 — KING DIAGNOSTICS GLUCOSE-O TEST (July 23, 1981)
  • K810089 — 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI (January 26, 1981)
  • K790319 — ORTHO-TOLUIDINE REAGENT SET (March 21, 1979)
  • K781308 — GLUCOLOUR (August 31, 1978)
  • K771091 — UNIPAK GLUCOSE (July 21, 1977)