Home / 510(k) Clearances / K780996

510(k) K780996

RUBELISA TEST KIT by Microbiological Assoc. — Product Code GON

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)
  • K802937 — RUBELLA VIRUS ANTIGENS & CONTROLS (December 31, 1980)
  • K802939 — HERPES SIMPLEX TYPE I (December 31, 1980)