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510(k) K250983

Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) by Asistan Medikal — Product Code SCL

K250983 is an FDA 510(k) premarket notification submitted by Asistan Medikal for the device "Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172)". The FDA issued a decision of Substantially Equivalent on January 30, 2026. The device falls under product code SCL (Allergen And Vaccine Delivery Needles), a Class II device regulated under 21 CFR 880.5570.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2026
Date Received
March 31, 2025
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.

Other clearances for product code SCL

  • 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)
  • K020523 — BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 (March 20, 2002)
  • K020500 — UNIVEC BIFURCATED SLIDING SHEATH SYRINGE (March 19, 2002)
  • K012515 — BIFURCATED VACCINATING NEEDLE (September 19, 2001)
  • K011979 — ALLERSHARP ALLERGY SKIN TESTER (September 14, 2001)

FDA data resources