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510(k) K893530

IRISTAIN FORMULA 2, PARTS 1 AND 2 by Intl. Remote Imaging Systems — Product Code JTS

K893530 is an FDA 510(k) premarket notification submitted by Intl. Remote Imaging Systems for the device "IRISTAIN FORMULA 2, PARTS 1 AND 2". The FDA issued a decision of Substantially Equivalent on June 13, 1989. The device falls under product code JTS (Stains, Microbiologic), a Class I device regulated under 21 CFR 864.1850. Intl. Remote Imaging Systems has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 1989
Date Received
May 8, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stains, Microbiologic
Device Class
Class I
Regulation Number
864.1850
Review Panel
MI
Submission Type

Other clearances by Intl. Remote Imaging Systems

  • K022774 — IQ 200 SYSTEM (October 21, 2002)
  • K000373 — 939UDX URINE PATHOLOGY SYSTEM (April 14, 2000)
  • K972141 — THE YELLOW IRIS URINALYSIS WORKSTATION (August 25, 1997)
  • K953116 — WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER (May 13, 1996)
  • K960054 — 900UDX URINE PATHOLOGY SYSTEM (March 22, 1996)
  • K954006 — YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY (March 12, 1996)
  • K943463 — THE YELLOW IRIS (September 20, 1994)
  • K934539 — THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABIL (March 30, 1994)
  • K914256 — YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU (May 1, 1992)
  • K874207 — THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION (January 5, 1988)

Other clearances for product code JTS

  • K960090 — CALCOFLUOR WHITE STAIN KIT (March 19, 1996)
  • K960095 — BACTIDROP CALCOFLUOR WHITE (March 19, 1996)
  • K920975 — BACTIDROP CALCOFLUOR WHITE (June 9, 1992)
  • K920976 — BACTIDROP INDIA INK (June 9, 1992)
  • K920970 — BACTIDROP KOH (10%) (June 9, 1992)
  • K890861 — ATS DOBELL & O'CONNOR'S IODINE (March 23, 1989)
  • K890020 — ATS LUGOL'S IODINE SOLUTION (February 24, 1989)
  • K884069 — SNAP N' STAIN IODINE STAIN (October 25, 1988)
  • K883052 — METHENO-STAIN KIT (August 30, 1988)
  • K883049 — ATS PARA-SET IODINE ALCOHOL SOLUTION (August 17, 1988)

FDA data resources