Beckman Anti-Streptolysin O Kit

• • Terminated Z-1152-04 FDA Unclassified (pre-2012) ·initiated 17 Dec 2003

  The ASO (MPE) assayed in Buffer cannot be programmed or calibrated using Array Calculator 5.

510(k) Number

K926236 ↗

FDA Product Code

GTQ

Device Class

Class I

Regulation

21 CFR Part 866.3720

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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