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510(k) K000299

DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D by Biomedex, Inc. — Product Code SCL

K000299 is an FDA 510(k) premarket notification submitted by Biomedex, Inc. for the device "DERMAPIK II SKIN TEST SYSTEM, DERMAPIK II (SINGLE TEST DEVICE), POLYPIK II (MULTIPLE SKIN TEST DEVICE), DERMAPIK TRAY, D". The FDA issued a decision of Substantially Equivalent on April 28, 2000. 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
April 28, 2000
Date Received
January 31, 2000
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

  • 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)
  • 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)

FDA data resources