Seracult Occult Bloof Test
FDA 510(k) K813204 · Propper Mfg. Co., Inc.
510(k) numberK813204
Submission
- Device name
- Seracult Occult Bloof Test
- Applicant
- Propper Mfg. Co., Inc.
Mchenry, IL, US - Received
- November 13, 1981
- Decision date
- January 28, 1982
- 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 |
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| K082620 | Once-A-Day Vertos Test PackJOJ · Abbreviated | 07/08/2009SE |
| K031152 | Propper Vapor Line PCD (Steam Sterilization Process Challenge Test)JOJ · Traditional | 08/17/2004SE |
| K991618 | Bi-O.K. Self-Contained Biological IndicatorFRC · Traditional | 01/24/2001SE |
| K991276 | Pass/Fail Challenge PackJOJ · Traditional | 07/12/1999SE |
| K973585 | Propper Eo Line Ethylene Oxide Sterilization IntegratorJOJ · Traditional | 11/06/1998SE |
| K972747 | Bi-O.K. Eo Gas Biological Test-Pak (269305,269310,269320)FRC · Traditional | 01/09/1998SE |
| K961156 | Once-A-Day Bowie and Dick Test Pack.JOJ · Traditional | 04/01/1997SE |
| K921798 | Propper Super Seracult(R)KHE · Traditional | 10/05/1992SE |
Questions and answers
When was Seracult Occult Bloof Test cleared by the FDA?
Seracult Occult Bloof Test (K813204) received a 510(k) decision of Substantially Equivalent on January 28, 1982, 76 days after the submission was received.
What is the product code of K813204?
The FDA product code is KHE – Reagent, Occult Blood, a Class II (moderate risk) device regulated under 21 CFR 864.6550.