FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALKALINE PHOSPHATASE REAGENT SET
K Number: K812837
·
Decision Jan 29, 1982
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
26
Review Days
112
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
- ALKALINE PHOSPHATASE REAGENT SET
- K Number
- K812837
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Anco Medical Reagents & Assoc.
- Date Received
- October 9, 1981
- Decision Date
- January 29, 1982
- Product Code
- CJL
- 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 |
|---|---|---|---|
| CJL | Beta Glycerophosphate, Alkaline Phosphatase Or Isoenzymes | FDA class 2 | Clinical Chemistry |
Other Clearances by Anco Medical Reagents & Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K842440 | SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH | Jul 27, 1984 | Substantially Equivalent |
| K831871 | SICKLE-HEME A/S CONTROLS & A/A CONTROL | Jul 28, 1983 | Substantially Equivalent |
| K821658 | HEMOGLOBIN REAGENT | Jun 25, 1982 | Substantially Equivalent |
| K821526 | ACID PHOSPHATASE REAGENT SET | Jun 10, 1982 | Substantially Equivalent |
| K821102 | MEGNESIUM REAGENT KIT | May 5, 1982 | Substantially Equivalent |
| K820951 | ENZYMATIC CHOLESTEROL KIT | Apr 26, 1982 | Substantially Equivalent |
| K820491 | SGPT REAGENT SET | Mar 11, 1982 | Substantially Equivalent |
| K820500 | TOTAL LIPID REAGENT SET | Mar 11, 1982 | Substantially Equivalent |
| K820466 | SGOT REAGENT SET | Mar 11, 1982 | Substantially Equivalent |
| K813415 | UREA NITROGEN REAGENT SET | Dec 31, 1981 | Substantially Equivalent |