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510(k) K896032

MODIFIED ELISA FOR CHLAMYDIA by Fairleigh Dickinson Laboratories, Inc. — Product Code LJC

K896032 is an FDA 510(k) premarket notification submitted by Fairleigh Dickinson Laboratories, Inc. for the device "MODIFIED ELISA FOR CHLAMYDIA". The FDA issued a decision of Substantially Equivalent on January 29, 1990. The device falls under product code LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)), a Class I device regulated under 21 CFR 866.3120. Fairleigh Dickinson Laboratories, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 1990
Date Received
October 16, 1989
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 Fairleigh Dickinson Laboratories, Inc.

  • K895187 — FDL, INC.'S TRANSPORT SYSTEM (October 24, 1989)
  • K883266 — FDL ELISA FOR CHLAMYDIA (October 25, 1988)
  • K881502 — BREWER GEL FOR CAMPYLOBACTER (April 27, 1988)
  • K875362 — BREWER GEL FOR ANAEROBES (January 27, 1988)
  • K853307 — DIRECT ELISA FOR HERPES SIMPLEX VIRUS (December 23, 1985)
  • K850251 — ROTALOK SURGICAL HAND TABLE (February 28, 1985)

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