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510(k) K934798

PATHODX CYTOMEGALOVIRUS by Diagnostic Products Corp. — Product Code LIN

K934798 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "PATHODX CYTOMEGALOVIRUS". The FDA issued a decision of Substantially Equivalent on March 25, 1994. The device falls under product code LIN (Antisera, Conjugated Fluorescent, Cytomegalovirus), a Class II device regulated under 21 CFR 866.3175. Diagnostic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 1994
Date Received
October 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Conjugated Fluorescent, Cytomegalovirus
Device Class
Class II
Regulation Number
866.3175
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 LIN

  • K081164 — D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT (June 13, 2008)
  • K983762 — NUCLISENS CMV PP67 (September 15, 1999)
  • K991650 — CMV BRITE TURBO KIT (July 12, 1999)
  • K951821 — CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY (June 7, 1996)
  • K951550 — CMV BRITE ANTIGENEMIA TEST KIT (January 30, 1996)
  • K921616 — CMV-VUE(TM) CMV ANTIGEN DETECTION KIT (August 11, 1992)
  • K912592 — CMV-EA MAB TEST (December 4, 1991)
  • K905257 — OPUS CMV TEST SYSTEM (April 17, 1991)
  • K904036 — BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN (October 16, 1990)
  • K894002 — CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY (August 10, 1989)

FDA data resources