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510(k) K771487

LEWIS BLOOD GROUP SUBSTANCE by Ortho Diagnostics, Inc. — Product Code KSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1977
Date Received
August 5, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
Device Class
Class II
Regulation Number
864.9160
Review Panel
HE
Submission Type

Other clearances by Ortho Diagnostics, Inc.

  • K802404 — ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE (October 23, 1980)
  • K801507 — ANTIGEN CONTROL CELLS (August 20, 1980)
  • K800357 — BI-LEVEL ASSAYED CARD. DRUG CONT., I,II (April 16, 1980)
  • K800310 — ORTHO ANTISERA CONTROL (March 5, 1980)
  • K791791 — ORTHO ANTIBODY ENHANCEMENT SOLUTION (October 11, 1979)
  • K791301 — ORTHO TSH RIA KIT (September 24, 1979)
  • K790813 — MULTECON BLOOD GAS CONTROL (June 28, 1979)
  • K782166 — SLIDE TEST FOR PREGNANCY, GRAVINDEX 90 (April 4, 1979)
  • K782063 — PREGNANCY, SENSIDEX TUBE TEST (April 4, 1979)
  • K781638 — RUBINDEX*DIRECT SYSTEM (December 20, 1978)

Other clearances for product code KSX

  • K802534 — GAMMA PI BLOOD GROUP SUBSTANCE (November 12, 1980)
  • K802533 — GAMMA LEWIS BLOOD GROUP SUBSTANCE (November 12, 1980)
  • K800916 — P1 BLOOD GROUP SUBSTANCE (May 8, 1980)
  • K781862 — BLOOD GROUP SUBSTANCE A (December 20, 1978)
  • K781895 — BLOOD GROUP SUBSTANCE B (December 20, 1978)
  • K781896 — BLOOD GROUP SUBSTANCE A,B (December 20, 1978)
  • K771488 — P1 BLOOD GROUP SUBSTANCE (November 8, 1977)