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510(k) K861631

SLIDE CULTURE U 'EIKEN' by Syn-Kit, Inc. — Product Code JXA

K861631 is an FDA 510(k) premarket notification submitted by Syn-Kit, Inc. for the device "SLIDE CULTURE U 'EIKEN'". The FDA issued a decision of Substantially Equivalent on June 10, 1986. The device falls under product code JXA (Kit, Screening, Urine), a Class I device regulated under 21 CFR 866.2660. Syn-Kit, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1986
Date Received
April 29, 1986
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 Syn-Kit, Inc.

  • K861098 — SEROIDEN STREPTO KIT 'EIKEN' (August 12, 1986)
  • K854819 — CPR SLIDE EIKEN (February 26, 1986)
  • K854820 — RA 80 EIKEN (January 17, 1986)
  • K853276 — ASO SLIDE EIKEN (August 20, 1985)
  • K843760 — UROPAPER EIKEN G (December 18, 1984)
  • K843753 — UROPAPER EIKEN GP (December 18, 1984)
  • K843757 — UROPAPER EIKEN AG (December 18, 1984)
  • K843758 — UROPAPER EIKEN GK (December 18, 1984)
  • K843755 — UROPAPER EIKEN 6B (December 18, 1984)
  • K843759 — UROPAPER EIKEN HAG (December 18, 1984)

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