Immunoscan(Tm) Direct Streptococcus Pneumoniae

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K870029 ↗

FDA Product Code

GWC

Device Class

Class I

Regulation

21 CFR Part 866.3740

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Trichrome Stain

  Class I

  FDA 510(k) K831060 Active Cleared 8 Jun 1983

• P & T Medium

  Class I

  FDA 510(k) K831059 Active Cleared 28 Apr 1983

• Immunoscan Rapid Direct Group a Strep Test

  Class I

  FDA 510(k) K854447 Active Cleared 3 Jan 1986

• Immunoscan Direct Hemophilus Influenzae Type B Tes

  Class II

  FDA 510(k) K854490 Active Cleared 27 Dec 1985

• Microdilution Panels

  Class II

  FDA 510(k) K862140 Active Cleared 16 Jul 1986

• Anaerobe Rapid Chromogenic Id Panel

  Class I

  FDA 510(k) K862332 Active Cleared 27 Aug 1986

See all devices from American Micro Scan →