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510(k) K771054

BLOOD COLLECTION TUBE, BLUE by Sherwood Medical Industries — Product Code GIM

K771054 is an FDA 510(k) premarket notification submitted by Sherwood Medical Industries for the device "BLOOD COLLECTION TUBE, BLUE". The FDA issued a decision of Substantially Equivalent on June 29, 1977. The device falls under product code GIM (Tubes, Vacuum Sample, With Anticoagulant), a Class II device regulated under 21 CFR 862.1675. Sherwood Medical Industries has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1977
Date Received
June 13, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vacuum Sample, With Anticoagulant
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

Other clearances by Sherwood Medical Industries

  • K801070 — SHERWOOD DISPOSABLE ENDOMETRIAL SAMPLES (July 21, 1980)
  • K801071 — LANCER GLUCOSE RATE REAGENT KIT (May 23, 1980)
  • K792013 — LANCER L-INA HUMAN REFERENCE SERUM (November 13, 1979)
  • K792014 — LANCER L-INA BUFFER, POLYMER, WASH SOLU (November 13, 1979)
  • K782077 — LANCER ICE CUBE (April 3, 1979)
  • K790523 — ARGYLE ESOPHAGEAL STETHOSCOPE (March 27, 1979)
  • K790196 — MONOJECT ARTERIAL BLOOD SAMPLING DEVICE (March 13, 1979)
  • K790197 — REAGENT KIT, LANCER GLUCOSE (March 12, 1979)
  • K781459 — MONOJECT SCALE MAGNIFIER (October 24, 1978)
  • K781060 — MONOJECT ENDOSSEOUS DENTAL IMPLANT (August 14, 1978)

Other clearances for product code GIM

  • K240455 — BD Vacutainer® Citrate Blood Collection Tubes (October 31, 2024)
  • K230493 — BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blo (November 27, 2023)
  • K213670 — BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collecti (August 25, 2023)
  • K162723 — TransFix/EDTA Vacuum Blood Collection Tubes (June 22, 2017)
  • K080552 — CYTO-CHEX BCT (July 31, 2008)
  • K012152 — DS30 HCY BLOOD COLLECTION TUBES (September 18, 2001)
  • K971449 — VACUTAINER BRAND PLUS TUBE WITH EDTA ANTICOAGULANT(MULTIPLE) (June 17, 1997)
  • K971221 — GREINER VACUETTE BLOOD COLLECTION TUBE (May 2, 1997)
  • K951886 — LOK-ON NEEDLE DISPOSAL SYSTEM (June 30, 1995)
  • K945458 — VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM (February 6, 1995)

FDA data resources