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510(k) K843382

UROCYSTIN by Mission Pharmacal Co. — Product Code JLC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1985
Date Received
August 28, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nitroprusside Reaction (Qualitative, Urine), Cystine
Device Class
Class I
Regulation Number
862.1240
Review Panel
CH
Submission Type

Other clearances by Mission Pharmacal Co.

  • K943010 — MAXILUBE (July 19, 1995)
  • K901223 — VACUUM ERECTION DEVICE (VED) (May 4, 1990)

Other clearances for product code JLC

  • K810514 — SANDARE NITROPRUSSIDE TEST PROCEDURE (March 4, 1981)