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510(k) K780996

RUBELISA TEST KIT by Microbiological Assoc. — Product Code GON

K780996 is an FDA 510(k) premarket notification submitted by Microbiological Assoc. for the device "RUBELISA TEST KIT". The FDA issued a decision of Substantially Equivalent on November 22, 1978. The device falls under product code GON (Antigen, Cf (Including Cf Control), Rubella), a Class II device regulated under 21 CFR 866.3510. Microbiological Assoc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1978
Date Received
June 13, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Control), Rubella
Device Class
Class II
Regulation Number
866.3510
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)
  • K781392 — CYTOMEGILISH TEST KIT (October 24, 1978)
  • K781143 — IMMUNOFLUORESCENCE TEST KIT (August 14, 1978)
  • K770764 — TISSUE CULTURE MEDIA W/HEPES BUFFER (July 21, 1977)
  • K770687 — MEASLESVIRUS FLOURE. CONJUGATED ANTISERU (June 14, 1977)

Other clearances for product code GON

  • K894262 — RUBELLA ANTIGEN AND CONTROL ANTIGEN (October 16, 1989)
  • K880157 — MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST (February 4, 1988)
  • K802939 — HERPES SIMPLEX TYPE I (December 31, 1980)
  • K802937 — RUBELLA VIRUS ANTIGENS & CONTROLS (December 31, 1980)

FDA data resources