510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920569Substantially Equivalent

Indxtm Dip-S-Tickstm

Intercare Diagnostics, Inc., Baltimore MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920569 is the FDA 510(k) clearance record for INDXTM DIP-S-TICKSTM, a class I device, cleared for Intercare Diagnostics, Inc. on under FDA product code LSQ (Reagent, Rickettsia Serological). FDA records list 5 510(k) clearances for Intercare Diagnostics, Inc., from to . As of , FDA records show no recalls naming K920569.

Clearance record

Decision date
Received
(368 days to decision)
Product code
LSQ Reagent, Rickettsia Serological
Regulation
21 CFR 866.3500
Device class
Class I
Review panel
Microbiology
Applicant
Intercare Diagnostics, Inc. P.O. Box 24124, Baltimore MD
510(k) summary
Statement
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