Product Code: CGE
FDA class 2
21 CFR 862.1345
Orthotoluidine, Glucose
Clinical Chemistry
The Orthotoluidine, Glucose test system (product code CGE) is an in-vitro diagnostic device used in clinical chemistry to measure glucose concentrations in biological specimens via the orthotoluidine colorimetric method. It is classified as FDA Class 2, representing moderate risk, and requires a 510(k) premarket notification prior to marketing. It falls under regulation 21 CFR 862.1345 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
510(k)s
12
FEI Numbers
0
Registration Numbers
0
Unique Applicants
12
Years Active
12
Basic Information
- Product Code
- CGE
- Device Class
- FDA class 2
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K890335 | SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. | Feb 17, 1989 | Substantially Equivalent | Alpkem Corp. |
| K855185 | GLUCOSE REAGENT SET | Jan 22, 1986 | Substantially Equivalent | Technostics Intl. |
| K850930 | GLUCOSE | Jun 10, 1985 | Substantially Equivalent | Dilab, Inc. |
| K841054 | DIRECT GLUCOSE REAGENT SET | May 01, 1984 | Substantially Equivalent | Medical Specialties, Inc. |
| K821198 | DIRECT GLUCOSE REAGENT SET | Jul 13, 1982 | Substantially Equivalent | Omega Medical Electronics |
| K811883 | KING DIAGNOSTICS GLUCOSE-O TEST | Jul 23, 1981 | Substantially Equivalent | King Diagnostics, Inc. |
| K810089 | 6% ORTHO LOLIUDINE REAGENT IN GLACID ACI | Jan 26, 1981 | Substantially Equivalent | Anco Medical Reagents & Assoc. |
| K790319 | ORTHO-TOLUIDINE REAGENT SET | Mar 21, 1979 | Substantially Equivalent | Fisher Scientific Co., LLC |
| K781308 | GLUCOLOUR | Aug 31, 1978 | Substantially Equivalent | Analytical & Research Chemicals, Inc. |
| K771314 | GLUCOSE REAGENT (O-TOLUIDINE) | Aug 03, 1977 | Substantially Equivalent | Mallinckrodt Critical Care |
| K771091 | UNIPAK GLUCOSE | Jul 21, 1977 | Substantially Equivalent | Harleco |
| K770455 | GLUCOSE PROCEDURE, TEKPOINT DIRECT | May 03, 1977 | Substantially Equivalent | Icn Pharmaceuticals, Inc. |