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510(k) K830342

CULUTURE SET CHLAMYDIA ISOLATION AND by Immulok, Inc. — Product Code LKI

K830342 is an FDA 510(k) premarket notification submitted by Immulok, Inc. for the device "CULUTURE SET CHLAMYDIA ISOLATION AND". The FDA issued a decision of Substantially Equivalent on May 4, 1983. The device falls under product code LKI (Antisera, Fluorescent, 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
May 4, 1983
Date Received
February 1, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, 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)
  • 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)
  • K821411 — HISTOSET IMMUNOPEROFIDASE TISSUE (June 25, 1982)

Other clearances for product code LKI

  • K914953 — IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY (February 19, 1992)
  • K905531 — LUPUS(LE)-LATEX TEST (January 25, 1991)
  • K894625 — CHLAMYDIA (LGV-1) (August 15, 1989)
  • K883776 — BTC CHLAMYDIA DIRECT SPECIMEN TEST & CONTROL SLIDE (February 3, 1989)
  • K854615 — MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES (January 28, 1986)

FDA data resources