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510(k) K852737

LACTOPLATE by Mackeen Consultants, Ltd. — Product Code DEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1985
Date Received
June 27, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lactoferrin, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5570
Review Panel
IM
Submission Type

Other clearances by Mackeen Consultants, Ltd.

  • K915062 — DOHLMAN DOANE KERATOPROTHESIS (January 21, 1992)

Other clearances for product code DEG

  • K071712 — LEUKO EZ VUE (December 4, 2007)
  • K042071 — IBD-SCAN (October 20, 2004)
  • K030704 — IBD-QUIK CHEK (April 21, 2003)
  • K011396 — IBD-CHEK (June 18, 2001)
  • K951101 — LEUKO-TEST (April 24, 1995)
  • K934473 — LACTOFERRIN MICROASSAY SYSTEM (December 3, 1993)
  • K931901 — LACTOCARD (July 6, 1993)