FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REAGENT, ALBUMIN DETERMINATION
K Number: K760473
·
Decision Oct 29, 1976
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
119
Applicant Total
14
Review Days
73
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Basic Information
- Device Name
- REAGENT, ALBUMIN DETERMINATION
- K Number
- K760473
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1035
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Simmler & Son, Inc.
- Date Received
- August 17, 1976
- Decision Date
- October 29, 1976
- Product Code
- CIX
- 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 |
|---|---|---|---|
| CIX | Bromcresol Green Dye-Binding, Albumin | FDA class 2 | Clinical Chemistry |
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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 |
| K760478 | REAGENT, BUN (UREA NITROGEN) DETERM. | Oct 29, 1976 | Substantially Equivalent |
| K760474 | REAGENT, ALKALINE PHOSPHATASE DETERM. | Oct 29, 1976 | Substantially Equivalent |
| K760480 | REAGENT, TOTAL PROTEIN DETERMINATION | Oct 29, 1976 | Substantially Equivalent |