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510(k) K792579

CULTURIA MACCONKEY/COLUMBIA CNA by Clinical Convenience Products, Inc. — Product Code JXA

K792579 is an FDA 510(k) premarket notification submitted by Clinical Convenience Products, Inc. for the device "CULTURIA MACCONKEY/COLUMBIA CNA". The FDA issued a decision of Substantially Equivalent on January 11, 1980. The device falls under product code JXA (Kit, Screening, Urine), a Class I device regulated under 21 CFR 866.2660. Clinical Convenience Products, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1980
Date Received
December 14, 1979
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.

  • K934759 — CULTURIA MACCONKEY-MUG (September 9, 1994)
  • 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)
  • 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)
  • K934759 — CULTURIA MACCONKEY-MUG (September 9, 1994)
  • K924218 — BAC-T-SCREEN (February 3, 1993)
  • K921045 — DIASLIDE URINE CULTURING DEVICE (September 28, 1992)

FDA data resources