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510(k) K781638

RUBINDEX*DIRECT SYSTEM by Ortho Diagnostics, Inc. — Product Code GOK

K781638 is an FDA 510(k) premarket notification submitted by Ortho Diagnostics, Inc. for the device "RUBINDEX*DIRECT SYSTEM". The FDA issued a decision of Substantially Equivalent on December 20, 1978. The device falls under product code GOK (Antisera, Hai (Including Hai Control), Rubella), a Class II device regulated under 21 CFR 866.3510. Ortho Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1978
Date Received
September 21, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Hai (Including Hai Control), Rubella
Device Class
Class II
Regulation Number
866.3510
Review Panel
MI
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)
  • K781860 — ASSAY, CHROMOGENIC ANTITHROMBIN III (December 4, 1978)

Other clearances for product code GOK

  • K832228 — RUBASCAN LATEX CARD TEST (September 29, 1983)
  • K810835 — RUBAZYME - M (May 5, 1981)
  • K792635 — ANTIBODY TO RUBELLA VIRUS (March 19, 1980)
  • K792133 — RUBELISA TEST KIT (January 11, 1980)
  • K790122 — RUBANON (February 15, 1979)
  • K781392 — CYTOMEGILISH TEST KIT (October 24, 1978)
  • K780010 — GOAT ANTI-RUBELLA ANTISERA (January 20, 1978)
  • K780063 — RUBENOSTICON (January 20, 1978)
  • K771956 — HUMAN O BUFFER (October 28, 1977)
  • K771957 — RUBELLA HEMAGGLUTINATION REAGENT KIT (October 28, 1977)

FDA data resources