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510(k) K902004

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

K902004 is an FDA 510(k) premarket notification submitted by The Upjohn Co. for the device "TROBICIN SUSCEPTIBILITY POWDER". The FDA issued a decision of Substantially Equivalent on May 15, 1990. The device falls under product code LOP (Solution, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. The Upjohn Co. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1990
Date Received
April 6, 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.

  • K900455 — ZEFAZONE SUSCEPTIBILITY POWDER (February 9, 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

  • K900455 — ZEFAZONE SUSCEPTIBILITY POWDER (February 9, 1990)
  • K810471 — STOCK ANTIMICROBIC SOLUTIONS (April 1, 1981)

FDA data resources