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510(k) K900870

PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST by Diagnostic Products Corp. — Product Code LJP

K900870 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST". The FDA issued a decision of Substantially Equivalent on April 16, 1990. The device falls under product code LJP (Antiserum, Fluorescent, Chlamydia Trachomatis), a Class I device regulated under 21 CFR 866.3120. Diagnostic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1990
Date Received
February 24, 1990
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 Diagnostic Products Corp.

  • K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (December 5, 2006)
  • K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (January 21, 2004)
  • K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER (December 12, 2003)
  • K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (October 10, 2003)
  • K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE (December 17, 2002)
  • K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODE (December 9, 2002)
  • K022603 — IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (August 21, 2002)
  • K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (July 22, 2002)
  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (June 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)

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)
  • 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)
  • K864128 — CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT (April 29, 1987)

FDA data resources