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510(k) K894805

RAPIDEC UR by Dms Products, Inc. — Product Code JXA

K894805 is an FDA 510(k) premarket notification submitted by Dms Products, Inc. for the device "RAPIDEC UR". The FDA issued a decision of Substantially Equivalent on September 26, 1989. The device falls under product code JXA (Kit, Screening, Urine), a Class I device regulated under 21 CFR 866.2660. Dms Products, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1989
Date Received
July 28, 1989
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 Dms Products, Inc.

  • K891004 — RAPIDEC STAPH (November 9, 1989)
  • K890626 — RAPIDEC COLI (June 2, 1989)
  • K890625 — JAMES REAGENT (February 17, 1989)
  • K854733 — API 20 EC (ENTEROBACTERIACEAE)(IDENTIFICATION KIT) (March 6, 1986)
  • K854732 — API 50 CHB (CULTURE MEDIA) (March 4, 1986)

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