Osom Ultra Strep a Test, Model 147

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K992658 ↗

FDA Product Code

GTY

Device Class

Class I

Regulation

21 CFR Part 866.3740

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Osom Card Ii Hcg-Urine Test, Model 102

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  FDA 510(k) K990578 Active Cleared 9 Mar 1999

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  FDA 510(k) K972231 Active Cleared 26 Aug 1997

• Osom Strep a Test

  Class I

  FDA 510(k) K961423 Active Cleared 11 Oct 1996

• Osom Card Hcg-Urine Test

  Class II

  FDA 510(k) K973879 Active Cleared 4 Nov 1997

• Perfecta Pregnancy Test

  Class II

  FDA 510(k) K965184 Active Cleared 4 Feb 1997

• Osom Hcg-Urine Test Model 101

  Class II

  FDA 510(k) K974159 Active Cleared 24 Dec 1997

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