Allergist Syringes

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K880894 ↗

FDA Product Code

FMF

Device Class

Class II

Regulation

21 CFR Part 880.5860

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Microscope Slides

  Class I

  FDA 510(k) K862112 Active Cleared 13 Jun 1986

• Sterile IV Set 4 Sizes

  Class II

  FDA 510(k) K832329 Active Cleared 24 Aug 1983

• Sterile, Foley Catheters W/Ptfe Coat

  Class II

  FDA 510(k) K841678 Active Cleared 19 Jul 1984

• Instrument Lubricant

  Not classified

  FDA 510(k) K780610 Active Cleared 31 May 1978

• Abco Mercurial Sphygmomanometer

  Class II

  FDA 510(k) K800236 Active Cleared 22 Feb 1980

• Abco Midstream Urine Collection Set

  Class I

  FDA 510(k) K800233 Active Cleared 26 Feb 1980

See all devices from Abco Dealers, Inc. →

• What are allergist syringes used for?

  Allergist syringes are medical devices used for administering allergen extracts in diagnostic and therapeutic procedures, designed for precise delivery of small volumes in allergy testing and immunotherapy.

• Are allergist syringes sterile or non-sterile when supplied?

  Allergist syringes are supplied non-sterile and are intended for single-use only, meaning they should not be reprocessed or reused after initial use.

• What is the FDA regulatory pathway for these allergist syringes?

  These allergist syringes are regulated under FDA 510(k) clearance K880894, which was granted on March 31, 1988, based on substantial equivalence to a legally marketed predicate device.