Mono-Latex (Tm) Slide Test

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K862008 ↗

FDA Product Code

KTN

Device Class

Class II

Regulation

21 CFR Part 866.5640

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Positive & Negative Hcg Urine Controls

  Class I

  FDA 510(k) K821742 Active Cleared 2 Jul 1982

• Bactogen-H. Influenzae Type B

  Class II

  FDA 510(k) K800493 Active Cleared 4 Apr 1980

• Bactigen(R) Group B Streptococcus Test

  Class I

  FDA 510(k) K885003 Active Cleared 7 Feb 1989

• Trojan Naturalamb Natural Membrane Condom W/Sperm.

  Class II

  FDA 510(k) K902305 Active Cleared 29 Mar 1991

• Bactigen Group B Streptococcus Test

  Class I

  FDA 510(k) K850772 Active Cleared 29 May 1985

• Brand Name 1-Step Pregnancy Test-May Be Marketed Under First Response, Answer, or Other Brand Names

  Class II

  FDA 510(k) K962183 Active Cleared 10 Jul 1996

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