FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE
K Number: K853244
·
Decision Aug 12, 1985
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
115
Applicant Total
23
Review Days
11
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
- TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE
- K Number
- K853244
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1635
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Simmler, Inc.
- Date Received
- August 1, 1985
- Decision Date
- August 12, 1985
- Product Code
- CEK
- 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 |
|---|---|---|---|
| CEK | Biuret (Colorimetric), Total Protein | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEK), ordered by most recent decision date.
HICHEM TOTAL PROTEIN REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CARESIDE TOTAL PROTEIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TOTAL PROTEIN OR TP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CSF/URINE TOTAL PROTEIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Simmler, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K895745 | SICKLE CELL SOLUBILITY TEST KIT | Nov 29, 1989 | Substantially Equivalent |
| K874903 | MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) | Feb 11, 1988 | Substantially Equivalent |
| K874595 | MULTICHEM (R) MAGNESIUM REAGENT | Jan 21, 1988 | Substantially Equivalent |
| K874820 | MULTICHEM HDL PRECIPITATING REAGENT #S0914 | Jan 7, 1988 | Substantially Equivalent |
| K874812 | MULTICHEM CHLORIDE REAGENT S0933 | Dec 18, 1987 | Substantially Equivalent |
| K874311 | MULTICHEM (R) TOTAL BILIRUBIN | Nov 25, 1987 | Substantially Equivalent |
| K874049 | MULTICHEM ALBUMIN REAGENT S0902 | Oct 29, 1987 | Substantially Equivalent |
| K874038 | MULTICHEM INORGANIC PHOSPHOROUS S0923 | Oct 28, 1987 | Substantially Equivalent |
| K873725 | MULTICHEM CREATININE REAGENT S0917 | Oct 20, 1987 | Substantially Equivalent |
| K873761 | MULTICHEM ALKALINE PHOSPHATASE (S0903) | Oct 7, 1987 | Substantially Equivalent |