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510(k) K882674

IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT by Icn Immunobiologicals — Product Code LKH

K882674 is an FDA 510(k) premarket notification submitted by Icn Immunobiologicals for the device "IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT". The FDA issued a decision of Substantially Equivalent on August 15, 1989. The device falls under product code LKH (Antisera, Immunoperoxidase, Chlamydia Spp.), a Class I device regulated under 21 CFR 866.3120. Icn Immunobiologicals has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1989
Date Received
June 28, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Immunoperoxidase, Chlamydia Spp.
Device Class
Class I
Regulation Number
866.3120
Review Panel
MI
Submission Type

Other clearances by Icn Immunobiologicals

  • K882369 — ACCRAASSAY RID KITS (July 12, 1988)

Other clearances for product code LKH

  • K910644 — IPAZYME (TM) CHLAMYDIA IGG-IGA (March 19, 1991)
  • K901975 — IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) (March 8, 1991)
  • K893669 — CELLMATICS SHLAMYDIA DETECTION SYSTEM (June 23, 1989)
  • K852869 — SELECTICULT-CHLAMYDIA (September 19, 1985)
  • K842151 — CHLAMYDIAE IMMUNOPEROXIDASE TEST KIT (July 20, 1984)
  • K830688 — COMBION SKIN TEST (March 31, 1983)
  • K820390 — HISTOSET IMMUNOPEROXIDASE TISSURE KIT (April 14, 1982)

FDA data resources