Home / 510(k) Clearances / K791397

510(k) K791397

HERPES EIA TEST KIT by Microbiological Assoc. — Product Code GQM

K791397 is an FDA 510(k) premarket notification submitted by Microbiological Assoc. for the device "HERPES EIA TEST KIT". The FDA issued a decision of Substantially Equivalent on September 24, 1979. The device falls under product code GQM (Antisera, Neutralization, Herpesvirus Hominis), a Class II device regulated under 21 CFR 866.3305. Microbiological Assoc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1979
Date Received
July 27, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Neutralization, Herpesvirus Hominis
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

Other clearances by Microbiological Assoc.

  • K792133 — RUBELISA TEST KIT (January 11, 1980)
  • 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)
  • K770687 — MEASLESVIRUS FLOURE. CONJUGATED ANTISERU (June 14, 1977)

Other clearances for product code GQM

  • K875367 — COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV (March 28, 1988)
  • K810043 — GOAT ANTI-HERPES SIMPLEX VIRUS TYPE I (May 15, 1981)

FDA data resources