Home / 510(k) Clearances / K900455

510(k) K900455

ZEFAZONE SUSCEPTIBILITY POWDER by The Upjohn Co. — Product Code LOP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1990
Date Received
January 30, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Solution, Antimicrobial
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

Other clearances by The Upjohn Co.

  • K902004 — TROBICIN SUSCEPTIBILITY POWDER (May 15, 1990)
  • K810853 — CK-TOTAL/CK-B (NAC) BIOLUMIN. ASSAY KIT (May 29, 1981)
  • K782009 — RIA KIT, PROGESTERONE (March 2, 1979)
  • K780792 — TESTOSTERONE RADIOIMMUNOASSAY KIT 125I (June 13, 1978)
  • K760920 — CAT-A-KIT (November 9, 1976)

Other clearances for product code LOP

  • K902004 — TROBICIN SUSCEPTIBILITY POWDER (May 15, 1990)
  • K810471 — STOCK ANTIMICROBIC SOLUTIONS (April 1, 1981)