Home / 510(k) Clearances / K820390

510(k) K820390

HISTOSET IMMUNOPEROXIDASE TISSURE KIT by Immulok, Inc. — Product Code LKH

K820390 is an FDA 510(k) premarket notification submitted by Immulok, Inc. for the device "HISTOSET IMMUNOPEROXIDASE TISSURE KIT". The FDA issued a decision of Substantially Equivalent on April 14, 1982. The device falls under product code LKH (Antisera, Immunoperoxidase, Chlamydia Spp.), a Class I device regulated under 21 CFR 866.3120. Immulok, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1982
Date Received
February 10, 1982
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 Immulok, Inc.

  • K830971 — HERPES SIMPLEX VIRUS TYPING REAGENTS (June 30, 1983)
  • K830342 — CULUTURE SET CHLAMYDIA ISOLATION AND (May 4, 1983)
  • K830250 — CVT VIRAL TRANSPORTS (February 28, 1983)
  • K823304 — RIASET PROLACTIN RIA KIT (December 22, 1982)
  • K822785 — FLUOROSET IMMUNOFLUORESCENT ANTIBODY (November 29, 1982)
  • K823055 — FLOUROSET IMMUNOFLUORESCENT ANTIBODY (November 5, 1982)
  • K822606 — CYTOMEGALOVIRUS ANTOBODY IGG (November 1, 1982)
  • K822605 — TOXOPLASMA GONDII ANTIBODY IGG (October 27, 1982)
  • K822607 — ANTINUCLEAR ANTOBODY CELL SUBSTRATE (September 17, 1982)
  • K821567 — IMMULOK CULTURESET (June 25, 1982)

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)
  • 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)

FDA data resources