Immunoccult-Lxi
FDA 510(k) K883432 · Intl. Immunoassay Laboratories, Inc.
510(k) numberK883432
Submission
- Device name
- Immunoccult-Lxi
- Applicant
- Intl. Immunoassay Laboratories, Inc.
Santa Clara, CA, US - Received
- August 15, 1988
- Decision date
- October 31, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KHE – Reagent, Occult Blood
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.6550
- Specialty
- Hematology
Other 510(k)s with product code KHE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood TestKHE · Traditional | Alfa Scientific Designs, Inc. | 02/15/2018SE |
| K170548 | InSure ONEKHE · Traditional | Enterix, Inc. | 10/05/2017SE |
| K171484 | hema-screen SPECIFIC GoldKHE · Special | Immunostics Inc., | 06/14/2017SE |
| K162333 | Wondfo One Step Fecal Occult Blood (FOB) TestKHE · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 05/14/2017SE |
| K163554 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestKHE · Special | Immunostics Inc., | 01/17/2017SE |
| K143325 | OC-Light S FITKHE · Traditional | Eiken Chemical Co., Ltd. | 08/20/2015SE |
| K121397 | Osom Ifob 25 Test and Patient Collection Kit Osom Ifob Control Kit Osom Ifob 50 Test KitKHE · Traditional | SEKISUI Diagnostics, LLC | 12/28/2012SE |
| K113506 | Ind One Step Occult Blood (Fob) TestKHE · Special | Ind Diagnostics, Inc. | 12/19/2012SE |
| K110309 | Fob One Step Rapid TestKHE · Traditional | Orient Gene Biotech | 09/14/2011SE |
| K102664 | Hema Screen ErKHE · Special | Immunostics Inc., | 01/28/2011SE |
More from Immunostics Inc.,
| 510(k) | Device | Decision |
|---|---|---|
| K913380 | MYDAS(TM)-MB2/MYDAS(TM)-MBJHX · Traditional | 04/22/1992SE |
| K913349 | Stambi-CkJHW · Traditional | 10/23/1991SE |
| K912231 | Proposed New Use of Instrument System and Test KitJHW · Traditional | 07/08/1991SE |
| K903441 | Mydas(Tm) Brand Solid-Phase Antibody ReagentsJHX · Traditional | 11/06/1990SE |
| K903508 | Labelling Changes to Impres-Mb-XJHW · Traditional | 09/07/1990SE |
| K901450 | Modified Label for Embria-Ck, Quick-Mb/Micromi-MbJHT · Traditional | 05/15/1990SE |
| K890609 | Impres-Mb (Addition of an Optional Test Procedure)CGS · Traditional | 03/16/1989SE |
| K890543 | Impres-Mb Reagent a and Reagent BJHX · Traditional | 03/13/1989SE |
| K883223 | Check-MmJHS · Traditional | 09/30/1988SE |
| K883222 | Isofor-Mm (TM)JHW · Traditional | 09/30/1988SE |
Questions and answers
When was Immunoccult-Lxi cleared by the FDA?
Immunoccult-Lxi (K883432) received a 510(k) decision of Substantially Equivalent on October 31, 1988, 77 days after the submission was received.
What is the product code of K883432?
The FDA product code is KHE – Reagent, Occult Blood, a Class II (moderate risk) device regulated under 21 CFR 864.6550.