Home / 510(k) Clearances / K830252

510(k) K830252

DIPCHEX DIP-SLIDE CULTURE SYS by Granite Diagnostics, Inc. — Product Code JXA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1983
Date Received
January 25, 1983
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 Granite Diagnostics, Inc.

  • K850969 — INHIBITORY MOLD AGAR PLATE (March 29, 1985)
  • K850970 — BRAIN HEART INFUSION AGAR W/5% SHEEP BLOOD, CHLORA (March 29, 1985)
  • K833254 — STREPTOCOCCUS ID TRIPLATE SYSTEM (October 28, 1983)
  • K832365 — TCBS AGAR (September 1, 1983)
  • K831349 — STREPTOCOCUS ID PLATE (May 16, 1983)
  • K830251 — CAMPY BLOOD AGAR PLATE (February 28, 1983)
  • K823122 — LAKED BLOOD AGAR W/PAROMOMYCIN & VANCOM (December 3, 1982)
  • K823248 — SCHAEDLER AGARS (December 3, 1982)
  • K823139 — SMITH'S MEDIUM (December 3, 1982)
  • K822997 — STREP SELECTIVE AGAR (November 17, 1982)

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)
  • K950246 — MULTIPLE (IZON URINE COLLECTION KIT) (March 21, 1995)
  • K950221 — MULTIPLE (IZON BLOOD & 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)