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510(k) K853067

FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT by Idt, A Division of Whittaker M.A. Bioproducts — Product Code GRE

K853067 is an FDA 510(k) premarket notification submitted by Idt, A Division of Whittaker M.A. Bioproducts for the device "FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT". The FDA issued a decision of Substantially Equivalent on October 22, 1985. The device falls under product code GRE (Antiserum, Fluorescent, Rubeola), a Class I device regulated under 21 CFR 866.3520. Idt, A Division of Whittaker M.A. Bioproducts has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1985
Date Received
July 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antiserum, Fluorescent, Rubeola
Device Class
Class I
Regulation Number
866.3520
Review Panel
MI
Submission Type

Other clearances by Idt, A Division of Whittaker M.A. Bioproducts

  • K853540 — FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY (February 4, 1986)
  • K782041 — FIAX TEST KIT (January 3, 1979)
  • K772219 — FIAX TEST FOR ANTI-RUBELLA ANTIBODY (January 20, 1978)
  • K772114 — FIAX C4 ASSAY (November 30, 1977)

Other clearances for product code GRE

  • K884004 — RUBEOLA TEST (December 5, 1988)
  • K821249 — ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS (July 30, 1982)
  • K770687 — MEASLESVIRUS FLOURE. CONJUGATED ANTISERU (June 14, 1977)

FDA data resources