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510(k) K893669

CELLMATICS SHLAMYDIA DETECTION SYSTEM by Difco Laboratories, Inc. — Product Code LKH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1989
Date Received
May 15, 1989
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

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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)
  • K882674 — IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT (August 15, 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)