Access Digiwipe System
FDA 510(k) K853141 · Medtech Products, Inc.
510(k) numberK853141
Submission
- Device name
- Access Digiwipe System
- Applicant
- Medtech Products, Inc.
Miami, FL, US - Received
- July 24, 1985
- Decision date
- November 18, 1985
- 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
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| K162333 | Wondfo One Step Fecal Occult Blood (FOB) TestKHE · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 05/14/2017SE |
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| 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 |
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| 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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Questions and answers
When was Access Digiwipe System cleared by the FDA?
Access Digiwipe System (K853141) received a 510(k) decision of Substantially Equivalent on November 18, 1985, 117 days after the submission was received.
What is the product code of K853141?
The FDA product code is KHE – Reagent, Occult Blood, a Class II (moderate risk) device regulated under 21 CFR 864.6550.