510(k) K953939

QUINTEST by Bayer Corp. — Product Code SCL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 13, 1995
Date Received: August 15, 1995
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 by Bayer Corp.

K024062 — ASCENSIA BREEZE BLOOD GLUCOSE METER (March 3, 2003)
K023944 — BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST (February 11, 2003)
K024017 — BAYER ADVIA CENTAUR HER-2/NEU ASSAY (January 30, 2003)
K024234 — ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL (January 23, 2003)
K022288 — COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED (December 17, 2002)
K023584 — ASCENSIA DEX 2 DIABETES CARE SYSTEM (November 20, 2002)
K020828 — CA 125 ASSAY FOR THE ADVIA CENTAUR SYSTEM (July 24, 2002)
K021428 — CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM (July 5, 2002)
K020806 — ACS:180 & ADVIA CENTAUR AFP IMMUNOASSAY (March 27, 2002)
K013568 — CEA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (December 21, 2001)

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)