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510(k) K920569

INDXTM DIP-S-TICKSTM by Intercare Diagnostics, Inc. — Product Code LSQ

K920569 is an FDA 510(k) premarket notification submitted by Intercare Diagnostics, Inc. for the device "INDXTM DIP-S-TICKSTM". The FDA issued a decision of Substantially Equivalent on February 9, 1993. The device falls under product code LSQ (Reagent, Rickettsia Serological), a Class I device regulated under 21 CFR 866.3500. Intercare Diagnostics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1993
Date Received
February 7, 1992
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 by Intercare Diagnostics, Inc.

  • K941938 — THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE (August 5, 1994)
  • K901597 — INDX DIP S TICKS (December 21, 1990)
  • K893895 — HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL (July 25, 1989)
  • K862948 — CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA) (October 17, 1986)

Other clearances for product code LSQ

  • K971591 — INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES T (March 13, 1998)
  • K901597 — INDX DIP S TICKS (December 21, 1990)
  • K872129 — LATEX R. CONORII (August 19, 1987)

FDA data resources