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510(k) K955776

ACU-LAB by Glederer & Co., Inc. — Product Code LDQ

K955776 is an FDA 510(k) premarket notification submitted by Glederer & Co., Inc. for the device "ACU-LAB". The FDA issued a decision of Substantially Equivalent on June 5, 1996. Glederer & Co., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1996
Date Received
December 20, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Glederer & Co., Inc.

  • K955661 — ACU-HALT (December 30, 1996)

Other clearances for product code LDQ

  • K993797 — EC-7701 FLUID WARMING CABINET (January 20, 2000)
  • K992258 — HOT SHOT FLUID WARMER IV FLUIDS (January 12, 2000)
  • K981032 — PIV SYSTEM (September 2, 1998)
  • K973747 — CONTROLLED TEMPERATURE CABINET SYSTEM (May 7, 1998)
  • K955661 — ACU-HALT (December 30, 1996)
  • K945374 — ACU-HALT (August 9, 1995)
  • K944961 — PERSONAL ALARM SYSTEM (PAS) (August 7, 1995)
  • K942810 — PALCO LABS COLD POUCH (June 28, 1995)
  • K930884 — MEDICAL PROCEDURE TRAY, MODIFICATION (March 21, 1995)
  • K934703 — MEDICOOL PROTECTALL (January 26, 1994)

FDA data resources