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510(k) K862948

CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA) by Intercare Diagnostics, Inc. — Product Code LJC

K862948 is an FDA 510(k) premarket notification submitted by Intercare Diagnostics, Inc. for the device "CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA)". The FDA issued a decision of Substantially Equivalent on October 17, 1986. The device falls under product code LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)), a Class I device regulated under 21 CFR 866.3120. Intercare Diagnostics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1986
Date Received
August 5, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
Device Class
Class I
Regulation Number
866.3120
Review Panel
MI
Submission Type

Other clearances by Intercare Diagnostics, Inc.

  • K941938 — THE MIRAGE SYSTEM BIOFEEDBACK INTERFACE (August 5, 1994)
  • K920569 — INDXTM DIP-S-TICKSTM (February 9, 1993)
  • K901597 — INDX DIP S TICKS (December 21, 1990)
  • K893895 — HEMATOLOGY CONTROL MIXTURES FOR QUALITY CONTROL (July 25, 1989)

Other clearances for product code LJC

  • K032330 — CT OIA (March 2, 2004)
  • K033865 — IDEIA PCE CHLAMYDIA (January 21, 2004)
  • K033079 — CHLAMYDIA IGG ELISA TEST SYSTEM (November 26, 2003)
  • K982210 — MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA (July 9, 1998)
  • K962558 — CHLAMYDIA IGG ELISA TEST SYSTEM (February 24, 1997)
  • K960850 — ACCESS CHLAMYDIA ASSAY (February 4, 1997)
  • K955627 — VIDAS CHLAMYDIA BLOCKING ASSAY (October 7, 1996)
  • K936054 — IMX SELECT CHLAMYDIA (May 30, 1996)
  • K940564 — IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION (January 11, 1996)
  • K951010 — CHLAMYDIA OIA (October 7, 1995)

FDA data resources