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510(k) K921045

DIASLIDE URINE CULTURING DEVICE by Savyon Diagnostics , Ltd. — Product Code JXA

K921045 is an FDA 510(k) premarket notification submitted by Savyon Diagnostics , Ltd. for the device "DIASLIDE URINE CULTURING DEVICE". The FDA issued a decision of Substantially Equivalent on September 28, 1992. The device falls under product code JXA (Kit, Screening, Urine), a Class I device regulated under 21 CFR 866.2660. Savyon Diagnostics , Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 28, 1992
Date Received
March 4, 1992
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 Savyon Diagnostics , Ltd.

  • K914327 — SEROELISA(TM) CHLAMYDIA IGA TEST KIT (June 9, 1992)
  • K915281 — SEROLISA CHLAMYDIA IGG TEST KIT (March 23, 1992)
  • K910644 — IPAZYME (TM) CHLAMYDIA IGG-IGA (March 19, 1991)
  • K901975 — IPAZYME(TM) CHLAMYDIA TRUE IGM(TM) (March 8, 1991)

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)
  • K911846 — URI-THREE(TM), MODIFICATION (October 4, 1991)

FDA data resources