Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
This device is a spectrophotometric clinical chemistry reagent system using 2,4-dinitrophenylhydrazine to measure ascorbic acid (Vitamin C) in patient specimens, used in the assessment of nutritional status and diagnosis of scurvy or conditions associated with vitamin C deficiency or excess. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls with no premarket submission. The product code is JMA, regulated under 21 CFR 862.1095, within the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JMA
- Device Class
- FDA class 1
- Regulation Number
- 862.1095
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K931523 | QUANTIMETRIX C-CLEAR(TM) | Jun 25, 1993 | Substantially Equivalent | Quantimetrix Corp. |
| K830978 | HELENA BIOSTRIP A | May 13, 1983 | Substantially Equivalent | Helena Laboratories |
| K822709 | URITEST 9, INLAB REAGENT STRIPS URINALY | Jan 28, 1983 | Substantially Equivalent | Laprol Scientific, Inc. |
FEI Numbers
This FDA classification entry is associated with 39 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 39 registration numbers. Click on an entry to view related FDA registrations.