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510(k) K830246

CAST SHOE, CAST BOOT by Warm & Form, Orthopedic Materials — Product Code JQB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 1983
Date Received
January 25, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kinetic Method, Gamma-Glutamyl Transpeptidase
Device Class
Class I
Regulation Number
862.1360
Review Panel
CH
Submission Type

Other clearances by Warm & Form, Orthopedic Materials

  • K830244 — TRACTION ACCESSORIES (March 9, 1983)
  • K830245 — HEAD HALTER (March 9, 1983)
  • K830243 — ABDUCTION PILLOW (March 8, 1983)
  • K823658 — DELUXE KNEE IMMOBILIZER(UNIVERSAL) (December 30, 1982)
  • K823660 — UNIVERSAL BUCKS TRACTION (December 30, 1982)
  • K823663 — ABDOMINAL BINDER (December 30, 1982)
  • K823662 — RIB BELT (UNIVERSAL) (December 30, 1982)
  • K823666 — UNIVERSAL WRIST SPLINT & FOREARM SPLINT (December 30, 1982)
  • K823665 — ROTATION BOOT (December 30, 1982)
  • K823659 — PELVIC TRACTION BELT (December 30, 1982)

Other clearances for product code JQB

  • K974000 — Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 (November 4, 1997)
  • K973157 — LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SET (October 10, 1997)
  • K971466 — SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT) (May 6, 1997)
  • K964457 — ROCHE COBAS IBTEGRA REAGENT CASSETTES (January 13, 1997)
  • K964916 — GAMMA-GLUTAMYL TRANSPEPTIDASE (January 10, 1997)
  • K955770 — GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM (September 9, 1996)
  • K945800 — Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 (June 9, 1995)
  • K946192 — HICHEM Y-GT REAGENT KIT (May 2, 1995)
  • K942962 — GGT QVET (December 7, 1994)
  • K935984 — GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419 (July 20, 1994)