Med-Pen/Med-Point
by Garid, Inc.
510(k) K853733
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK853733 | Date4 Dec 1986 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CGA
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1345
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The MED-PEN/MED-POINT is a glucose monitoring device classified under Clinical Chemistry. It utilizes glucose oxidase technology to measure glucose levels for diagnostic purposes. This device is designed for clinical laboratory use and is part of the glucose monitoring product category.
The MED-PEN/MED-POINT is supplied as a Class 2 medical device with FDA 510K clearance (K853733) under regulation 862.1345. It is manufactured by Garid, Inc. and received FDA approval on December 4, 1986. The device is intended for professional use in clinical settings and is not specified as single-use or reusable in the available data.
Other devices from Garid, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the MED-PEN/MED-POINT device used for?
The MED-PEN/MED-POINT is a glucose monitoring device classified under Clinical Chemistry that utilizes glucose oxidase technology to measure glucose levels for diagnostic purposes in clinical laboratory settings.
How is the MED-PEN/MED-POINT supplied and what is its intended use?
The device is supplied as a Class 2 medical device manufactured by Garid, Inc. It is intended for professional use in clinical settings and is not specified as single-use or reusable in the available data.
What regulatory approvals does the MED-PEN/MED-POINT have?
The MED-PEN/MED-POINT has FDA 510K clearance (K853733) under regulation 862.1345. It received FDA approval on December 4, 1986, and is classified as substantially equivalent.
What technology does the MED-PEN/MED-POINT utilize for glucose measurement?
The device utilizes glucose oxidase technology to measure glucose levels for diagnostic purposes. This technology is specifically designed for clinical laboratory use as part of the glucose monitoring product category.