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510(k) K922792

ZITHROMAX by Difco Laboratories, Inc. — Product Code JNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1992
Date Received
June 9, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chromatographic, Phospholipids
Device Class
Class I
Regulation Number
862.1575
Review Panel
CH
Submission Type

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Other clearances for product code JNT

  • K914040 — PHOSPHOLIPID REAGENT SET (October 30, 1991)
  • K792349 — SUSCEPTIBILITY DISK, CINOXACIN 100 MCG. (March 12, 1980)