Intl. Remote Imaging Systems
Chatsworth, CA, US
Intl. Remote Imaging Systems appears in FDA device records in Chatsworth, CA. FDA records list 14 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 14
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 14 510(k) clearances for Intl. Remote Imaging Systems between 1982 and 2002. The busiest year on record is 1996, with 3. The most recent is 2002, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1983 | 2 |
| 1988 | 1 |
| 1989 | 1 |
| 1992 | 1 |
| 1994 | 2 |
| 1996 | 3 |
| 1997 | 1 |
| 2000 | 1 |
| 2002 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K022774 | IQ 200 SYSTEM | LKM | Substantially Equivalent | |
| K000373 | 939UDX URINE PATHOLOGY SYSTEM | LKM | Substantially Equivalent | |
| K972141 | THE YELLOW IRIS URINALYSIS WORKSTATION | KQO | Substantially Equivalent | |
| K953116 | WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER | GKZ | Substantially Equivalent | |
| K960054 | 900UDX URINE PATHOLOGY SYSTEM | KQO | Substantially Equivalent | |
| K954006 | YELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITY | GKL | Substantially Equivalent | |
| K943463 | THE YELLOW IRIS | KQO | Substantially Equivalent | |
| K934539 | THE YELLOW IRIS URINALYSIS WORKSTATION WITH IRISCOPE BODY FLUID ANALYSIS CAPABILITY | GKL | Substantially Equivalent | |
| K914256 | YELLOW IRIS URINALYSIS WRKSTA W/IRISCOPE BDY FLU | GKL | Substantially Equivalent | |
| K893530 | IRISTAIN FORMULA 2, PARTS 1 AND 2 | JTS | Substantially Equivalent | |
| K874207 | THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION | IBJ | Substantially Equivalent | |
| K832713 | IRI SPEC URINALYSIS CONTROL | JJW | Substantially Equivalent | |
| K830220 | YELLOW IRIS TM | KQO | Substantially Equivalent | |
| K821503 | IRIS URINE STAIN | ICF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain