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510(k) K884517

PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED by Kallestad Diag, A Div. of Erbamont, Inc. — Product Code LJC

K884517 is an FDA 510(k) premarket notification submitted by Kallestad Diag, A Div. of Erbamont, Inc. for the device "PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED". The FDA issued a decision of Substantially Equivalent on November 30, 1988. The device falls under product code LJC (Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)), a Class I device regulated under 21 CFR 866.3120. Kallestad Diag, A Div. of Erbamont, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1988
Date Received
October 27, 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 Kallestad Diag, A Div. of Erbamont, Inc.

  • K910885 — QM300 CALIBRATOR G PACK (June 17, 1991)
  • K910886 — QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK (June 17, 1991)
  • K910887 — QM300 CONTROL G PACK (June 17, 1991)
  • K904725 — CHLAMYDIA SYSTEM SOFTWARE (CSS) (January 14, 1991)
  • K902253 — PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT (July 26, 1990)
  • K902462 — MODIFIED QM300 RHEUMATOID FACTOR TEST (June 21, 1990)
  • K900010 — NDS CORTISOL TEST KIT AND NDS CORTISOL CALIBRATOR (April 3, 1990)
  • K897072 — NDS THYROXINE TEST KIT & NDS THYROXINE CALIBRATOR (March 29, 1990)
  • K900009 — NDS THEOPHYLLINE TEST KIT & NDS TDM CALIBRATOR SET (March 29, 1990)
  • K894947 — PLATELIA TOXO IGG KIT (March 23, 1990)

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