hema-screen SPECIFIC Gold
FDA 510(k) K171484 · Immunostics Inc.,
510(k) numberK171484
Submission
- Device name
- hema-screen SPECIFIC Gold
- Applicant
- Immunostics Inc.,
Ocean, NJ, US - Received
- May 22, 2017
- Decision date
- June 14, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K100031 | Ind One Step Fecal Occult Blood Test Model 440-10KHE · Traditional | Ind Diagnostic, Inc. | 07/19/2010SE |
More from Ind Diagnostic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K221817 | ALFIS Vitamin D, ALFIS-3 AnalyzerMRG · Traditional | 09/22/2023SE |
| K182298 | hemochroma PLUS SystemGKR · Traditional | 11/16/2018SE |
| K163465 | hemochroma PLUS SystemGKR · Traditional | 09/08/2017SE |
| K163225 | AFIAS iFOB with AFIAS-50OOX · Traditional | 08/08/2017SE |
| K163554 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestKHE · Special | 01/17/2017SE |
| K102664 | Hema Screen ErKHE · Special | 01/28/2011SE |
| K060463 | Hema Screen Specific IfobtKHE · Traditional | 06/06/2006SE |
| K041728 | HCG Detector Combi, HCG Detector Stix, HCG Detector CassetteJHI · Traditional | 08/11/2004SE |
| K031490 | RubellacolLQN · Traditional | 07/16/2003SE |
| K992759 | Colon Alert TestKHE · Traditional | 12/06/1999SE |
Questions and answers
When was hema-screen SPECIFIC Gold cleared by the FDA?
hema-screen SPECIFIC Gold (K171484) received a 510(k) decision of Substantially Equivalent on June 14, 2017, 23 days after the submission was received.
What is the product code of K171484?
The FDA product code is KHE – Reagent, Occult Blood, a Class II (moderate risk) device regulated under 21 CFR 864.6550.