FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SODIUM REAGENT SET
K Number: K902572
·
Decision Jul 10, 1990
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
13
Review Days
29
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
- SODIUM REAGENT SET
- K Number
- K902572
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1665
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Tech Intl. Co.
- Date Received
- June 11, 1990
- Decision Date
- July 10, 1990
- Product Code
- CEI
- 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 |
|---|---|---|---|
| CEI | Uranyl Acetate/Zinc Acetate, Sodium | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEI), ordered by most recent decision date.
SODIUM TEST KIT AND ELETROLYTE CAL 1 AND 2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SODIUM REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SODIUM TEST KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Tech Intl. Co.
| K Number | Device Name | ||
|---|---|---|---|
| K915704 | AMYLASE (KINETIC) REAGENT SET | Jun 28, 1996 | Substantially Equivalent |
| K915705 | ACID PHOSPHATASE REAGENT SET | Feb 27, 1992 | Substantially Equivalent |
| K915707 | AMMONIA REAGENT SET | Feb 26, 1992 | Substantially Equivalent |
| K914158 | URIC ACID REAGENT SET | Feb 21, 1992 | Substantially Equivalent |
| K915706 | LIPASE REAGENT SET | Feb 18, 1992 | Substantially Equivalent |
| K915710 | AMYLASE (COLORIMETRIC) REAGENT SET | Jan 30, 1992 | Substantially Equivalent |
| K914160 | CHOLESTEROL REGEANT SET | Jan 30, 1992 | Substantially Equivalent |
| K915709 | CREATINE KINASE-MB (CK-MB) REAGENT SET | Jan 27, 1992 | Substantially Equivalent |
| K914159 | GLUCOSE REAGENT SET | Jan 27, 1992 | Substantially Equivalent |
| K915708 | INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET | Jan 22, 1992 | Substantially Equivalent |