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510(k) K883266

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

K883266 is an FDA 510(k) premarket notification submitted by Fairleigh Dickinson Laboratories, Inc. for the device "FDL ELISA FOR CHLAMYDIA". The FDA issued a decision of Substantially Equivalent on October 25, 1988. 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
October 25, 1988
Date Received
August 3, 1988
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.

  • K896032 — MODIFIED ELISA FOR CHLAMYDIA (January 29, 1990)
  • K895187 — FDL, INC.'S TRANSPORT SYSTEM (October 24, 1989)
  • 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