IP Specific E

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K821094 ↗

FDA Product Code

DGO

Device Class

Class II

Regulation

21 CFR Part 866.5510

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Polystyrene Microtiter Plate Immuno-

  Class II

  FDA 510(k) K832344 Active Cleared 21 Nov 1983

• Allergen Immunosorbents Ip Specific E

  Not classified

  FDA 510(k) K831496 Active Cleared 8 Aug 1983

• Polystyrene Microtiter Well Immunosor

  Class II

  FDA 510(k) K832345 Active Cleared 25 Nov 1983

• Polystyrene Micro-Liter Plate-Birchtree

  Class II

  FDA 510(k) K831984 Active Cleared 21 Nov 1983

• Logipe a Data Reducsystem Ip Specific-

  Class II

  FDA 510(k) K831774 Active Cleared 18 Jul 1983

• Ip Specific G

  Class II

  FDA 510(k) K830005 Active Cleared 2 Jun 1983

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• What is IP Specific E used for?

  IP Specific E is an in vitro diagnostic device used in the field of immunology for laboratory testing purposes, specifically classified as Ige, Peroxidase, Antigen, Antiserum, Control under regulation number 866.5510.

• How is IP Specific E supplied and where is it intended for use?

  IP Specific E is supplied as a diagnostic reagent and is intended for use in clinical laboratory settings, as stated in the device description for immunology testing applications.

• Does IP Specific E have FDA clearance and what is its regulatory classification?

  IP Specific E has received FDA 510(k) clearance under number K821094 and is classified as a Class II medical device, based on the authorization and clearance details provided in the device data.