510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971591Substantially Equivalent

Indx Dip-S-Ticks Scrub Typhus Test for the Detection of Igg and Igm Antibodies to Orientia Tsutsugamushi (Scrub Typhus)

David C. Bishop, Ph.D., Dowingtown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971591 is the FDA 510(k) clearance record for INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS), a class I device, cleared for David C. Bishop, Ph.D. on under FDA product code LSQ (Reagent, Rickettsia Serological). FDA records list one 510(k) clearance for David C. Bishop, Ph.D. As of , FDA records show no recalls naming K971591.

Clearance record

Decision date
Received
(316 days to decision)
Product code
LSQ Reagent, Rickettsia Serological
Regulation
21 CFR 866.3500
Device class
Class I
Review panel
Microbiology
Applicant
David C. Bishop, Ph.D. 605 Dilworth Rd., Dowingtown PA
510(k) summary
Summary
Third party review
No

Clearances, product code LSQ

Trailing 12 months

FDA records hold no clearances under product code LSQ in the trailing twelve months.

FDA records show no clearances under product code LSQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LSQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260