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510(k) K901975

IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) by Savyon Diagnostics , Ltd. — Product Code LKH

K901975 is an FDA 510(k) premarket notification submitted by Savyon Diagnostics , Ltd. for the device "IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)". The FDA issued a decision of Substantially Equivalent on March 8, 1991. The device falls under product code LKH (Antisera, Immunoperoxidase, Chlamydia Spp.), a Class I device regulated under 21 CFR 866.3120. Savyon Diagnostics , Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1991
Date Received
May 1, 1990
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 Savyon Diagnostics , Ltd.

  • K921045 — DIASLIDE URINE CULTURING DEVICE (September 28, 1992)
  • K914327 — SEROELISA(TM) CHLAMYDIA IGA TEST KIT (June 9, 1992)
  • K915281 — SEROLISA CHLAMYDIA IGG TEST KIT (March 23, 1992)
  • K910644 — IPAZYME (TM) CHLAMYDIA IGG-IGA (March 19, 1991)

Other clearances for product code LKH

  • K910644 — IPAZYME (TM) CHLAMYDIA IGG-IGA (March 19, 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)
  • K820390 — HISTOSET IMMUNOPEROXIDASE TISSURE KIT (April 14, 1982)

FDA data resources