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510(k) K840709

MID-STREAM URINE COLLECTION SETS by Concord Laboratories, Inc.

K840709 is an FDA 510(k) premarket notification submitted by Concord Laboratories, Inc. for the device "MID-STREAM URINE COLLECTION SETS". The FDA issued a decision of Substantially Equivalent on April 3, 1984. Concord Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 1984
Date Received
February 17, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Concord Laboratories, Inc.

  • K883840 — DRI-VENT ARTERIAL BLOOD SAMPLING KIT (May 16, 1989)
  • K871825 — MECONIUM SUCTION CATHETER (June 29, 1987)
  • K864535 — TRACHEOBRONCHIAL SUCTION CATHETER, CAT. NO. 6110 (January 6, 1987)
  • K862039 — CONCORD CARE TRAY (July 3, 1986)
  • K854601 — SPRING GUIDE CATHETER ANESTHESIA CONDUCTION CATH (January 10, 1986)
  • K854327 — SUBCUTANEOUS TUNNELING NEEDLES & HANDLES (November 13, 1985)
  • K851134 — REGIONAL ANESTHESIA TRAYS (July 15, 1985)
  • K842095 — EPIDURAL TRAYS (July 3, 1984)
  • K841486 — ARTERIAL BLOOD SAMPLING KITS (May 23, 1984)
  • K840987 — VAPORIZED HEPARIN (April 5, 1984)

FDA data resources