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510(k) K802939

HERPES SIMPLEX TYPE I by Orion Diagnostica, Inc. — Product Code GON

K802939 is an FDA 510(k) premarket notification submitted by Orion Diagnostica, Inc. for the device "HERPES SIMPLEX TYPE I". The FDA issued a decision of Substantially Equivalent on December 31, 1980. The device falls under product code GON (Antigen, Cf (Including Cf Control), Rubella), a Class II device regulated under 21 CFR 866.3510. Orion Diagnostica, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1980
Date Received
November 19, 1980
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 Orion Diagnostica, Inc.

  • K142993 — QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, (March 10, 2016)
  • K043125 — ORION DIAGNOSTICA UNIQ PINP RIA (May 4, 2005)
  • K042625 — QUIKREAD CRP CALIBRATOR SET (November 18, 2004)
  • K042442 — QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD 101 INSTRUMENT, MODE (September 24, 2004)
  • K942286 — DIARLEX ROTA-ADENO (December 14, 1994)
  • K914892 — SALIVA-STIM (September 2, 1992)
  • K904655 — PYLORISET (October 21, 1991)
  • K884074 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN G (October 27, 1988)
  • K884147 — IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M (October 27, 1988)
  • K884075 — IMMUNOCHEMICAL DETERMINATION OF TRANSFERRIN (October 19, 1988)

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)
  • K780996 — RUBELISA TEST KIT (November 22, 1978)

FDA data resources