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510(k) K770687

MEASLESVIRUS FLOURE. CONJUGATED ANTISERU by Microbiological Assoc. — Product Code GRE

K770687 is an FDA 510(k) premarket notification submitted by Microbiological Assoc. for the device "MEASLESVIRUS FLOURE. CONJUGATED ANTISERU". The FDA issued a decision of Substantially Equivalent on June 14, 1977. The device falls under product code GRE (Antiserum, Fluorescent, Rubeola), a Class I device regulated under 21 CFR 866.3520. Microbiological Assoc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1977
Date Received
April 13, 1977
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 Microbiological Assoc.

  • K792133 — RUBELISA TEST KIT (January 11, 1980)
  • K791397 — HERPES EIA TEST KIT (September 24, 1979)
  • K781549 — TOXELISA TEST KIT (December 7, 1978)
  • K780996 — RUBELISA TEST KIT (November 22, 1978)
  • K781392 — CYTOMEGILISH TEST KIT (October 24, 1978)
  • K781143 — IMMUNOFLUORESCENCE TEST KIT (August 14, 1978)
  • K770764 — TISSUE CULTURE MEDIA W/HEPES BUFFER (July 21, 1977)

Other clearances for product code GRE

  • K884004 — RUBEOLA TEST (December 5, 1988)
  • K853067 — FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT (October 22, 1985)
  • K821249 — ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS (July 30, 1982)

FDA data resources