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510(k) K862354

MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT by Synbiotics Corp. — Product Code LJP

K862354 is an FDA 510(k) premarket notification submitted by Synbiotics Corp. for the device "MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT". The FDA issued a decision of Substantially Equivalent on September 29, 1986. The device falls under product code LJP (Antiserum, Fluorescent, Chlamydia Trachomatis), a Class I device regulated under 21 CFR 866.3120. Synbiotics Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1986
Date Received
June 20, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Fluorescent, Chlamydia Trachomatis
Device Class
Class I
Regulation Number
866.3120
Review Panel
MI
Submission Type

Other clearances by Synbiotics Corp.

  • K883235 — RAPIDTEST-HCG (TM) (September 30, 1988)
  • K873784 — NOVA STREP A (November 12, 1987)

Other clearances for product code LJP

  • K063675 — DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KIT (September 24, 2007)
  • K941714 — CHLAMYDIA TRACHOMATIS ANTIGEN TEST (July 18, 1994)
  • K901243 — CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST (May 21, 1990)
  • K900870 — PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST (April 16, 1990)
  • K895839 — PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1 (February 1, 1990)
  • K883352 — FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTI (October 6, 1988)
  • K881500 — ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TEST (April 27, 1988)
  • K880031 — PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS (March 17, 1988)
  • K872744 — MODIFIED CHLAMYSET ANTIGEN (September 22, 1987)
  • K872903 — MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT. (August 6, 1987)

FDA data resources