Home / 510(k) Clearances / K971591

510(k) K971591

INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS) by David C. Bishop, Ph.D. — Product Code LSQ

K971591 is an FDA 510(k) premarket notification submitted by David C. Bishop, Ph.D. for the device "INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS)". The FDA issued a decision of Substantially Equivalent on March 13, 1998. The device falls under product code LSQ (Reagent, Rickettsia Serological), a Class I device regulated under 21 CFR 866.3500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1998
Date Received
May 1, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Reagent, Rickettsia Serological
Device Class
Class I
Regulation Number
866.3500
Review Panel
MI
Submission Type

Other clearances for product code LSQ

  • K920569 — INDXTM DIP-S-TICKSTM (February 9, 1993)
  • K901597 — INDX DIP S TICKS (December 21, 1990)
  • K872129 — LATEX R. CONORII (August 19, 1987)

FDA data resources