FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REAGENTS-4 FOR URIC ACID DETERMINATION
K Number: K760477
·
Decision Oct 29, 1976
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
14
Applicant Total
14
Review Days
73
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
- REAGENTS-4 FOR URIC ACID DETERMINATION
- K Number
- K760477
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Simmler & Son, Inc.
- Date Received
- August 17, 1976
- Decision Date
- October 29, 1976
- Product Code
- CDH
- 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 |
|---|---|---|---|
| CDH | Acid, Uric, Phosphotungstate Reduction | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDH), ordered by most recent decision date.
URIC ACID
FDA 510(k)
FDA Class 1
·Clinical Chemistry
URIC ACID REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
URIC ACID REAGENT SET
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PHOSPHOTUNGSTATE REDUCTION, URIC ACID
FDA 510(k)
FDA Class 1
·Clinical Chemistry
URIC ACID (TPTZ) COLORINMETRIC
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Simmler & Son, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K780817 | GLOBIN-TERGE | Jul 27, 1978 | Substantially Equivalent |
| K771903 | LIPASE | Dec 6, 1977 | Substantially Equivalent |
| K771906 | PHOSPHATE | Dec 6, 1977 | Substantially Equivalent |
| K771905 | GLYCEROL SUBSTRATE | Dec 6, 1977 | Substantially Equivalent |
| K771904 | GLYCEROL KINASE | Dec 6, 1977 | Substantially Equivalent |
| K761086 | REAGENTS | Jan 12, 1977 | Substantially Equivalent |
| K760476 | REAGENT, LACTATE DEHYDROGENASE | Nov 1, 1976 | Substantially Equivalent |
| K760473 | REAGENT, ALBUMIN DETERMINATION | Oct 29, 1976 | Substantially Equivalent |
| K760478 | REAGENT, BUN (UREA NITROGEN) DETERM. | Oct 29, 1976 | Substantially Equivalent |
| K760474 | REAGENT, ALKALINE PHOSPHATASE DETERM. | Oct 29, 1976 | Substantially Equivalent |