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510(k) K020523

BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 by Bd — Product Code SCL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2002
Date Received
February 19, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Allergen And Vaccine Delivery Needles
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

An allergen delivery needle is a device intended to percutaneously deliver diagnostic allergenic extracts for use in allergy skin tests also referred to as skin prick tests or intradermal allergy tests.

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Other clearances for product code SCL

  • K250983 — Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS (January 30, 2026)
  • K222385 — Bifurcated Needle (December 6, 2022)
  • K182582 — Oryum and Ovem Epidermal Deri Prick Test Applicator (April 10, 2019)
  • K172062 — AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Tes (March 5, 2018)
  • K162917 — Allerhope Allergy Skin Tester (August 17, 2017)
  • K032528 — BD ECLIPSE BIFURCATED NEEDLE (September 9, 2003)
  • K031630 — BIFURCATED ALLERGY SKIN TESTING NEEDLE (August 7, 2003)
  • K020500 — UNIVEC BIFURCATED SLIDING SHEATH SYRINGE (March 19, 2002)
  • K012515 — BIFURCATED VACCINATING NEEDLE (September 19, 2001)
  • K011979 — ALLERSHARP ALLERGY SKIN TESTER (September 14, 2001)