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510(k) K830688

COMBION SKIN TEST by Nicholas H. Maganias — Product Code LKH

K830688 is an FDA 510(k) premarket notification submitted by Nicholas H. Maganias for the device "COMBION SKIN TEST". The FDA issued a decision of Substantially Equivalent on March 31, 1983. The device falls under product code LKH (Antisera, Immunoperoxidase, Chlamydia Spp.), a Class I device regulated under 21 CFR 866.3120. Nicholas H. Maganias has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1983
Date Received
March 4, 1983
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 Nicholas H. Maganias

  • K833999 — COMBION SKIN TEST - FOUR PRONG (September 5, 1984)

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)
  • K820390 — HISTOSET IMMUNOPEROXIDASE TISSURE KIT (April 14, 1982)

FDA data resources