Home / 510(k) Clearances / K802423

510(k) K802423

PHADEBACT HAEMOPHILUS TEST by Pharmacia, Inc. — Product Code GRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1980
Date Received
October 3, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Fluorescent, All Types, Hemophilus Spp.
Device Class
Class II
Regulation Number
866.3300
Review Panel
MI
Submission Type

Other clearances by Pharmacia, Inc.

  • K974350 — ALLERGAN IMMUNO CAP M4, M8, K70 (February 9, 1998)
  • K972364 — UNICAP PHADIATOP (September 4, 1997)
  • K972068 — UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82 (July 3, 1997)
  • K970420 — MASTERCAP AM 5.0/MASTERCAP RM 5.0 (June 30, 1997)
  • K964152 — UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH (April 23, 1997)
  • K962274 — UNICAP 100 (September 12, 1996)
  • K941993 — PHARMACIA CAP SYSTEM PHADIATOP FEIA (January 30, 1996)
  • K954337 — GENOTROPIN MIXER (November 13, 1995)
  • K951025 — PISTON SYRINGE (October 19, 1995)
  • K952025 — ROBOCAP (July 26, 1995)

Other clearances for product code GRO

  • K851271 — LEGIONELLA CULTURE CONFIRMATIN KIT (July 8, 1985)
  • K834067 — LEGIONELLA DIFFERENTIATION DISK (January 3, 1984)
  • K800493 — BACTOGEN-H. INFLUENZAE TYPE B (April 4, 1980)