Home / 510(k) Clearances / K905385

510(k) K905385

P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN by Virion (U.S.), Inc. — Product Code GQS

K905385 is an FDA 510(k) premarket notification submitted by Virion (U.S.), Inc. for the device "P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN". The FDA issued a decision of Substantially Equivalent on March 21, 1991. The device falls under product code GQS (Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4), a Class I device regulated under 21 CFR 866.3400. Virion (U.S.), Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1991
Date Received
November 30, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4
Device Class
Class I
Regulation Number
866.3400
Review Panel
MI
Submission Type

Other clearances by Virion (U.S.), Inc.

  • K933251 — EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST (June 13, 1994)
  • K921618 — COXSACKIE VIRUS B1-B6 CF ANTIGENS (June 29, 1992)
  • K905306 — MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN (June 17, 1991)
  • K864981 — TOXOPLASMA GONDII (October 30, 1987)

Other clearances for product code GQS

  • K093415 — D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KIT (December 23, 2009)
  • K943557 — IMAGEN (January 9, 1995)
  • K884194 — PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT (November 22, 1988)
  • K884193 — PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT (November 22, 1988)
  • K871232 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3 (June 26, 1987)
  • K871234 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1 (June 26, 1987)
  • K871228 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 (June 26, 1987)
  • K843665 — PARAINFLUENZA 1 (September 26, 1985)
  • K843667 — PARAINFLUENZA 3 (September 26, 1985)
  • K802935 — PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR (December 31, 1980)

FDA data resources