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510(k) K891175

EDL ABNORMAL COAGULATION CONTROL by Elite Diagnostic , Ltd. — Product Code GGL

K891175 is an FDA 510(k) premarket notification submitted by Elite Diagnostic , Ltd. for the device "EDL ABNORMAL COAGULATION CONTROL". The FDA issued a decision of Substantially Equivalent on April 10, 1989. The device falls under product code GGL (Control, White-Cell), a Class II device regulated under 21 CFR 864.8625. Elite Diagnostic , Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1989
Date Received
March 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, White-Cell
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

Other clearances by Elite Diagnostic , Ltd.

  • K891370 — EDL ONE-STAGE PROTHROMBIN TIME REAGENT (April 21, 1989)
  • K890859 — EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME (April 21, 1989)
  • K891179 — EDL NORMAL COAGULATION CONTROL (April 10, 1989)
  • K890619 — EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT (March 15, 1989)

Other clearances for product code GGL

  • K083926 — CD4 COUNT (February 11, 2009)
  • K051633 — CD-CHEX PLUS BC (August 16, 2005)
  • K993126 — CD-CHEX CD 34 (November 26, 1999)
  • K960894 — CD-CHEX + RBC (May 24, 1996)
  • K931825 — CD-CHEX CD4 LOW (June 6, 1994)
  • K920997 — CD-CHEX (May 31, 1992)
  • K894651 — COULTER POSITIVE CONTROL CELLS (September 13, 1989)

FDA data resources