Irma-Count(Tm) Pap, (RKPA1, RKPA2)

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K895723 ↗

FDA Product Code

JFH

Device Class

Class II

Regulation

21 CFR Part 862.1020

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Immulite 2000 3RD Generation Psa

  Class II

  FDA 510(k) K974842 Active Cleared 21 Apr 1998

• Immulite Turbo Ck-Mb, Models LSKCP1, LSKCP5

  Class II

  FDA 510(k) K991797 Active Cleared 9 Jun 1999

• Coat-A-Count T4 Ria Kit

  Class II

  FDA 510(k) K811315 Active Cleared 27 May 1981

• Immulite(R) Tbg

  Class I

  FDA 510(k) K950072 Active Cleared 3 Apr 1995

• Immulite 2000 Digoxin, Models L2KDI2 (200 Tests) and L2KDI6 (600 Tests)

  Class II

  FDA 510(k) K012301 Active Cleared 19 Sep 2001

• Coat-A-Count Direct Androstenedione

  Class I

  FDA 510(k) K954755 Active Cleared 29 Nov 1995

See all devices from Diagnostic Products Corp. →

• What is the IRMA-COUNT PAP device used for?

  The IRMA-COUNT PAP is a laboratory device designed for measuring acid phosphatase (prostatic) that is tartrate inhibited. It is classified under clinical chemistry and intended for use in medical laboratory settings.

• Is the IRMA-COUNT PAP a single-use device?

  Yes, the IRMA-COUNT PAP is supplied as a single-use product and is not MRI safe. It should be used according to the manufacturer's instructions and discarded after a single use.

• What are the regulatory details for the IRMA-COUNT PAP?

  The IRMA-COUNT PAP is authorized under FDA 510(k) clearance with product code JFH and regulation number 862.1020. It was manufactured by Diagnostic Products Corp. and received clearance on October 31, 1989.

• How should the IRMA-COUNT PAP be stored?

  The IRMA-COUNT PAP should be stored according to the manufacturer's instructions. Specific storage conditions are not detailed in the provided information, so users should refer to the product documentation for proper storage requirements.