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510(k) K831253

LANCER HEMOGLOBIN ANALYZER REAGENTS by Sherwood Medical Co. — Product Code KMG

K831253 is an FDA 510(k) premarket notification submitted by Sherwood Medical Co. for the device "LANCER HEMOGLOBIN ANALYZER REAGENTS". The FDA issued a decision of Substantially Equivalent on May 9, 1983. The device falls under product code KMG (Purifier, Water, Ultraviolet, Medical), a Class II device regulated under 21 CFR 880.6710. Sherwood Medical Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1983
Date Received
April 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Purifier, Water, Ultraviolet, Medical
Device Class
Class II
Regulation Number
880.6710
Review Panel
HO
Submission Type

Other clearances by Sherwood Medical Co.

  • K981365 — MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS (November 25, 1998)
  • K960982 — MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. A (December 23, 1996)
  • K962880 — SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM (December 9, 1996)
  • K960574 — ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC C (August 5, 1996)
  • K960677 — KANGAROO JEJUNAL FEEDING SYSTEM (May 13, 1996)
  • K960632 — KANGAROO FEEDING TUBE PLACMENT STYLET (May 9, 1996)
  • K955831 — ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM (March 28, 1996)
  • K954429 — KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT (March 8, 1996)
  • K954525 — SENSI-TOUCH EPIDURAL ANESTHESIA FILTER (January 19, 1996)
  • K950201 — ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER (December 15, 1995)

Other clearances for product code KMG

  • K012029 — REMEDY MODEL 2Z12 (December 31, 2001)
  • K832288 — HEMOGLOBINOMETER (September 1, 1983)
  • K813050 — AQUANOMICS, #MP4SF (December 2, 1981)
  • K813048 — AQUANOMICS, #MP2SF (December 2, 1981)
  • K813047 — AQUANOMICS, MINI 60L (December 2, 1981)
  • K813045 — AQUANOMICS, #SP36SF (December 2, 1981)
  • K813049 — AQUANOMICS, #HHU100 (December 2, 1981)
  • K813046 — AQUANOMICS, #HHU60 (December 2, 1981)

FDA data resources