FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MAGNESIUM REAGENT SET
K Number: K882256
·
Decision Aug 8, 1988
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
89
Applicant Total
20
Review Days
69
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MAGNESIUM REAGENT SET
- K Number
- K882256
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1495
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Tech-Neal Scientific, Inc.
- Date Received
- May 31, 1988
- Decision Date
- August 8, 1988
- Product Code
- JGJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JGJ | Photometric Method, Magnesium | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JGJ), ordered by most recent decision date.
Magnesium
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Magnesium
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Randox RX Daytona Plus Magnesium (MG)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Atellica CH Magnesium (Mg)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACE MAGNESIUM REGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MAGNESIUM ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Tech-Neal Scientific, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K882459 | DIAZO, COLORIMETRIC BILIRUBIN | Aug 2, 1988 | Substantially Equivalent |
| K881239 | GAMMA GLUTAMYL TRANSFERASE REAGENT SET | May 31, 1988 | Substantially Equivalent |
| K881241 | TOTAL BILIRUBIN REAGENT | May 27, 1988 | Substantially Equivalent |
| K880237 | CHOLESTEROL | Apr 28, 1988 | Substantially Equivalent |
| K881237 | CREATINE KINASE (CK) REAGENT SET | Apr 28, 1988 | Substantially Equivalent |
| K881240 | CHLORIDE REAGENT SET | Apr 28, 1988 | Substantially Equivalent |
| K880277 | URIC ACID REAGENT SET | Apr 18, 1988 | Substantially Equivalent |
| K880845 | CALCIUM REAGENT SET | Apr 5, 1988 | Substantially Equivalent |
| K880842 | LDH-L REAGENT SET | Apr 5, 1988 | Substantially Equivalent |
| K880844 | ALBUMIN REAGENT SET | Apr 5, 1988 | Substantially Equivalent |