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510(k) K801507

ANTIGEN CONTROL CELLS by Ortho Diagnostics, Inc. — Product Code GOL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1980
Date Received
June 30, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Ha (Including Ha Control), Rubella
Device Class
Class II
Regulation Number
866.3510
Review Panel
MI
Submission Type

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  • 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)
  • K781860 — ASSAY, CHROMOGENIC ANTITHROMBIN III (December 4, 1978)

Other clearances for product code GOL

  • K841174 — RUBELLA ANTIBODY FLUOROIMMUNOASSAY (June 7, 1984)
  • K834032 — RUBAQUICK DIAGNOSTIC KIT (April 17, 1984)
  • K810309 — RUBELLA ANTIBODIES TEST REAGENTS (March 11, 1981)
  • K802508 — RUBELISA IGM TEST KIT (December 18, 1980)
  • K802339 — EIA RUBELLA-G (December 18, 1980)
  • K802102 — RUBELLA ELISA REAGENTS RUBELLA IGG ANTI (December 18, 1980)
  • K801667 — GAMMA COAT(125 I) RUBELLA ANTIBODY (October 23, 1980)
  • K801098 — ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES) (September 16, 1980)
  • K800789 — RUBELLA BIO-BEAD TITRATION KIT (June 30, 1980)
  • K800797 — MACRO-VUE RUBELLA CARD TEST (June 20, 1980)