INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS)— 510(k) K971591

Name: FDA 510(k) clearance K971591
Creator: U.S. Food and Drug Administration
Published: 1998-03-13

Substantially Equivalent

David C. Bishop, Ph.D.

FDA 510(k) clearance K971591 for INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS), Substantially Equivalent on 1998-03-13. Applicant: David C. Bishop, Ph.D.. Device class: 1.

Clearance details

Applicant: David C. Bishop, Ph.D.
Product code: Code LSQ
Device class: Class 1
Regulation: 21 CFR 866.3500
Advisory panel: Microbiology
Date received: 1997-05-01
Decision date: 1998-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dowingtown, PA, US

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