Iristain Formula 2, Parts 1 and 2
FDA 510(k) K893530 · Intl. Remote Imaging Systems
510(k) numberK893530
Submission
- Device name
- Iristain Formula 2, Parts 1 and 2
- Applicant
- Intl. Remote Imaging Systems
Chatsworth, CA, US - Received
- May 8, 1989
- Decision date
- June 13, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTS – Stains, Microbiologic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.1850
- Specialty
- Hematology
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| K890861 | Ats Dobell & O'Connor's IodineJTS · Traditional | Alpha-Tec Systems, Inc. | 03/23/1989SE |
| K890020 | Ats Lugol's Iodine SolutionJTS · Traditional | Alpha-Tec Systems, Inc. | 02/24/1989SE |
| K884069 | Snap N' Stain Iodine StainJTS · Traditional | Scientific Device Laboratory, Inc. | 10/25/1988SE |
| K883052 | Metheno-Stain KitJTS · Traditional | Scientific Device Laboratory, Inc. | 08/30/1988SE |
| K883061 | Ats Para-Set Carbol-Xylene SolutionJTS · Traditional | Alpha-Tech Systems, Inc. | 08/17/1988SE |
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| K953116 | White Iris Leukocyte Differential AnalyzerGKZ · Traditional | 05/13/1996SE |
| K960054 | 900UDX Urine Pathology SystemKQO · Traditional | 03/22/1996SE |
| K954006 | Yellow Iris Urinalysis Workstation W/Iriscope Body Fluid Analysis CapabilityGKL · Traditional | 03/12/1996SE |
| K943463 | The Yellow IrisKQO · Traditional | 09/20/1994SE |
| K934539 | The Yellow Iris Urinalysis Workstation with Iriscope Body Fluid Analysis CapabilityGKL · Traditional | 03/30/1994SE |
| K914256 | Yellow Iris Urinalysis Wrksta W/Iriscope Bdy FluGKL · Traditional | 05/01/1992SE |
| K874207 | The Purple Iris(Tm) Cytopathology WorkstationIBJ · Traditional | 01/05/1988SE |
Questions and answers
When was Iristain Formula 2, Parts 1 and 2 cleared by the FDA?
Iristain Formula 2, Parts 1 and 2 (K893530) received a 510(k) decision of Substantially Equivalent on June 13, 1989, 36 days after the submission was received.
What is the product code of K893530?
The FDA product code is JTS – Stains, Microbiologic, a Class I (low risk) device regulated under 21 CFR 864.1850.