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GEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST

Gen-Probe, Inc. · Class I · Cleared Mar 11, 1994

K-numberK924715
Device nameGEN-PROBE DIRECT GROUP A STREPTOCOCUS TEST
ApplicantGen-Probe, Inc.
Product codeMDK
Device classClass I
Decision dateMar 11, 1994
DecisionSubstantially Equivalent
Regulation866.3740
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View the full FDA submission: accessdata.fda.gov

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