TANDEM M-PAK PAP Immunoenzymetric Assay

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

Full name

Tandem(R) M-Pak(Tm) Pap Immunoenzymetric Assay

510(k) Number

K864945 ↗

FDA Product Code

JFH

Device Class

Class II

Regulation

21 CFR Part 862.1020

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Tandem Icon II Hcg Immunoenzymetric Assay Kit

  Class II

  FDA 510(k) K860542 Active Cleared 5 Mar 1986

• Tandem-E Lh Immunoenzymetric Assay Kit

  Class I

  FDA 510(k) K895094 Active Cleared 31 Oct 1989

• Tandem-E Thyroid Stimulating Hormone Kit

  Class II

  FDA 510(k) K832813 Active Cleared 31 Oct 1983

• Tandem-E -Fer Immunoenzymetric Kit

  Class II

  FDA 510(k) K823871 Active Cleared 25 Feb 1983

• Photon Immunoassay Analyzer

  Class I

  FDA 510(k) K832364 Active Cleared 26 Aug 1983

• Tandem HCG Kit

  Class II

  FDA 510(k) K820822 Active Cleared 29 Apr 1982

See all devices from Hybritech, Inc. →

• What is the TANDEM M-PAK PAP Immunoenzymetric Assay used for?

  The TANDEM M-PAK PAP Immunoenzymetric Assay is a laboratory test used for the quantitative determination of prostate-specific antigen (PSA) in human serum, which serves as a biomarker for monitoring prostate conditions.

• How is the TANDEM M-PAK PAP Assay supplied and what are its usage requirements?

  The assay is supplied as a kit for in vitro diagnostic use and is intended for professional laboratory settings. It is a single-use device with specific storage requirements, though sterility status is not specified in the provided data.

• What is the regulatory status of the TANDEM M-PAK PAP Assay?

  The device has FDA 510(k) clearance with product code JFH and is classified under regulation number 862.1020. It was received by the FDA on December 17, 1986, and cleared on January 5, 1987.

• What method does the TANDEM M-PAK PAP Assay use to measure PSA levels?

  This assay utilizes immunoenzymetric methods to measure PSA levels in human serum, providing quantitative results for clinical evaluation of prostate conditions.