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510(k) K934759

CULTURIA MACCONKEY-MUG by Clinical Convenience Products, Inc. — Product Code JXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1994
Date Received
October 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Screening, Urine
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Clinical Convenience Products, Inc.

  • K870502 — CULTURIA MACCONKEY-MUG/MODIFIED TSA SYSTEMS (February 26, 1987)
  • K864764 — CULTURIA MACCONKEY-MUG/CLED SYSTEMS (December 29, 1986)
  • K800215 — CULTURIA MACCONKEY/CLED #DM87 (February 13, 1980)
  • K792579 — CULTURIA MACCONKEY/COLUMBIA CNA (January 11, 1980)
  • K792284 — CULTURIA EMB/COLUMBIA CNA W/5% SHEEP (December 19, 1979)

Other clearances for product code JXA

  • K011043 — OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) (November 30, 2001)
  • K981084 — URISCREEN (October 7, 1998)
  • K972676 — URINE SCREENING DEVICE (February 23, 1998)
  • K952246 — TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT (June 20, 1995)
  • K950257 — MULTIPLE (IZON DBS & URINE COLLECTION KIT) (April 14, 1995)
  • K950221 — MULTIPLE (IZON BLOOD & URINE COLLECTION KIT) (March 21, 1995)
  • K950246 — MULTIPLE (IZON URINE COLLECTION KIT) (March 21, 1995)
  • K924218 — BAC-T-SCREEN (February 3, 1993)
  • K921045 — DIASLIDE URINE CULTURING DEVICE (September 28, 1992)
  • K911846 — URI-THREE(TM), MODIFICATION (October 4, 1991)