Cleared Traditional

ACCU-STAPH

K820347 · Carr-Scarborough Microbiologicals, Inc. · Microbiology
Mar 1982
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K820347 is an FDA 510(k) clearance for the ACCU-STAPH, a Staphylococcus Aureus Somatic Antigens (Class I — General Controls, product code LHT), submitted by Carr-Scarborough Microbiologicals, Inc. (Walker, US). The FDA issued a Cleared decision on March 4, 1982, 24 days after receiving the submission on February 8, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3700.

Submission Details

510(k) Number K820347 FDA.gov
FDA Decision Cleared SESE
Date Received February 08, 1982
Decision Date March 04, 1982
Days to Decision 24 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LHT — Staphylococcus Aureus Somatic Antigens
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3700

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