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510(k) K872129

LATEX R. CONORII by Health Research, Inc. — Product Code LSQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1987
Date Received
June 2, 1987
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 Health Research, Inc.

  • K860557 — LATEX R. TYPHI (April 21, 1986)
  • K843794 — LATEX-R RICKETTSII (January 4, 1985)

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)
  • K920569 — INDXTM DIP-S-TICKSTM (February 9, 1993)
  • K901597 — INDX DIP S TICKS (December 21, 1990)