Company ยท US
Intl. Remote Imaging Systems
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 2002. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 2002 | K022774 | IQ 200 SYSTEM Intl. Remote Imaging Systems | LKM |
| Apr 14, 2000 | K000373 | 939UDX URINE PATHOLOGY SYSTEM Intl. Remote Imaging Systems | LKM |
| Aug 25, 1997 | K972141 | THE YELLOW IRIS URINALYSIS WORKSTATION Intl. Remote Imaging Systems | KQO |
| May 13, 1996 | K953116 | WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER Intl. Remote Imaging Systems | GKZ |
| Mar 22, 1996 | K960054 | 900UDX URINE PATHOLOGY SYSTEM Intl. Remote Imaging Systems | KQO |
| Mar 12, 1996 | K954006 | YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY Intl. Remote Imaging Systems | GKL |
| Sep 20, 1994 | K943463 | THE YELLOW IRIS Intl. Remote Imaging Systems | KQO |
| Mar 30, 1994 | K934539 | THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY Intl. Remote Imaging Systems | GKL |
| May 1, 1992 | K914256 | YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU Intl. Remote Imaging Systems | GKL |
| Jun 13, 1989 | K893530 | IRISTAIN FORMULA 2, PARTS 1 AND 2 Intl. Remote Imaging Systems | JTS |
| Jan 5, 1988 | K874207 | THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION Intl. Remote Imaging Systems | IBJ |
| Dec 22, 1983 | K832713 | IRI SPEC URINALYSIS CONTROL Intl. Remote Imaging Systems | JJW |
| Jun 17, 1983 | K830220 | YELLOW IRIS TM Intl. Remote Imaging Systems | KQO |
| Jun 3, 1982 | K821503 | IRIS URINE STAIN Intl. Remote Imaging Systems | ICF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||