Home / 510(k) Clearances / K871228

510(k) K871228

ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 by Microscan Div. Baxter Healthcare Corp. — Product Code GQS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1987
Date Received
March 27, 1987
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 Microscan Div. Baxter Healthcare Corp.

  • K871229 — ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL (June 26, 1987)
  • K871234 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1 (June 26, 1987)
  • K871232 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3 (June 26, 1987)
  • K871231 — ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B (June 26, 1987)
  • K871233 — ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A (June 26, 1987)
  • K871230 — ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS (June 26, 1987)
  • K870814 — HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2 (June 4, 1987)
  • K870074 — GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS (April 14, 1987)
  • K871033 — RABBIT KIDNEY CULTURE CELLS (FIRST PASS) (March 31, 1987)
  • K870089 — IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KIT (March 17, 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)
  • K905385 — P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGEN (March 21, 1991)
  • K884193 — PARAINFLUENZA TYPE 3 IFA TEST KIT FOR ANTI. DETECT (November 22, 1988)
  • K884194 — PARAINFLUENZA TYPE 1 IFA TEST KIT FOR ANTI. DETECT (November 22, 1988)
  • K871234 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1 (June 26, 1987)
  • K871232 — ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3 (June 26, 1987)
  • K843667 — PARAINFLUENZA 3 (September 26, 1985)
  • K843665 — PARAINFLUENZA 1 (September 26, 1985)
  • K802935 — PARAINFLUENZA 1,2, & 3 ANTIGENS & CONTR (December 31, 1980)