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510(k) K870946

MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST by Serono Diagnostics, Inc. — Product Code LJP

K870946 is an FDA 510(k) premarket notification submitted by Serono Diagnostics, Inc. for the device "MONABRITE CHLAMYDIA TRACHOMATIS DIR. SPECIMEN TEST". The FDA issued a decision of Substantially Equivalent on April 29, 1987. The device falls under product code LJP (Antiserum, Fluorescent, Chlamydia Trachomatis), a Class I device regulated under 21 CFR 866.3120. Serono Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1987
Date Received
March 9, 1987
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 Serono Diagnostics, Inc.

  • K953598 — SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS (March 11, 1996)
  • K942051 — SR1 DHEA-S ENZYME IMMUNOASSAY (July 13, 1994)
  • K883085 — T3 UPTAKE SEROZYME ENZYME IMMUNO KT/MAG SOLID PHAS (September 9, 1988)
  • K882340 — LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA (August 8, 1988)
  • K880388 — T3 SEROZYME ENZYMEIMMUNOASSAY KIT, MAG SOLID PHASE (March 3, 1988)
  • K874866 — T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE (February 11, 1988)
  • K873431 — PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH (October 20, 1987)
  • K873186 — LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA (September 29, 1987)
  • K873400 — PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA (September 25, 1987)
  • K872862 — PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS (September 18, 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