Home / 510(k) Clearances / K883282

510(k) K883282

VIRGO HSV-1 IGG ELISA by Electro-Nucleonics, Inc. — Product Code GQO

K883282 is an FDA 510(k) premarket notification submitted by Electro-Nucleonics, Inc. for the device "VIRGO HSV-1 IGG ELISA". The FDA issued a decision of Substantially Equivalent on March 10, 1989. The device falls under product code GQO (Antisera, Cf, Herpesvirus Hominis 1,2), a Class II device regulated under 21 CFR 866.3305. Electro-Nucleonics, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1989
Date Received
August 3, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Cf, Herpesvirus Hominis 1,2
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

Other clearances by Electro-Nucleonics, Inc.

  • K893718 — DELTATEST (R) LIPASE II (September 28, 1989)
  • K883670 — SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI (April 28, 1989)
  • K883281 — VIRGO HSV-2 IGG ELISA (March 10, 1989)
  • K883427 — VIRGO(R) VZV-IGG ELISA (March 10, 1989)
  • K883102 — VIRGO (R) CMV-IGG ELISA (February 8, 1989)
  • K884784 — VIRGO(R) MICROWELL ALT ASSAY (December 29, 1988)
  • K883205 — ALTLTS ALANINE AMINO TRANSFERASE ALT (September 9, 1988)
  • K883206 — LACTATE DEHYDROGENASE LDH (September 9, 1988)

Other clearances for product code GQO

  • K883281 — VIRGO HSV-2 IGG ELISA (March 10, 1989)
  • K881261 — BION HSV1-G OR HSV2-G TEST SYSTEM (June 7, 1988)
  • K875366 — THE DDI SERODOT HERPES IGG TEST KIT (May 23, 1988)
  • K871426 — VIROGEN HSV ANTIBODY TEST (October 15, 1987)
  • K861120 — THE GOLDEN QUAD TEST (HSV) (February 2, 1987)
  • K854712 — VISIBLE-HERPES TM TEST SYSTEM (May 20, 1986)
  • K852782 — HSVI - IGG ELISA-KIT (January 21, 1986)
  • K852781 — HSV2 - IGG ELISA-KIT (January 21, 1986)
  • K842531 — AMIZYME-HSV TYPES 1 & 2 TEST KITS (December 6, 1985)
  • K842663 — ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2 (December 6, 1985)

FDA data resources