FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SANDARE ACID PHOSPHATASE PROCEDURE
K Number: K842516
·
Decision Aug 17, 1984
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
1
Applicant Total
23
Review Days
38
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
- SANDARE ACID PHOSPHATASE PROCEDURE
- K Number
- K842516
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1020
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sandare Chemical Co., Inc.
- Date Received
- July 10, 1984
- Decision Date
- August 17, 1984
- Product Code
- CJR
- 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 |
|---|---|---|---|
| CJR | Acid Phosphatase, Thymol Blue Monophosphate | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CJR), ordered by most recent decision date.
View allOther Clearances by Sandare Chemical Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K872852 | EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST | Sep 29, 1987 | Substantially Equivalent |
| K862556 | SANDARE GLYCOHEMOGLOBIN PROCEDURE | Aug 8, 1986 | Substantially Equivalent |
| K860684 | SANDARE BCG ALBUMIN PROCEDURE | Mar 17, 1986 | Substantially Equivalent |
| K851395 | SANDARE IRON-BINDING CAPACITY PROCEDURE | May 7, 1985 | Substantially Equivalent |
| K851394 | SANDARE IRON PROCEDURE | Apr 30, 1985 | Substantially Equivalent |
| K844498 | SANDARE ALKALINE PHOSPHATASE PROCEDURE | Dec 10, 1984 | Substantially Equivalent |
| K833898 | TRI-LEVEL BILIRUBIN CONTROLS | Jan 13, 1984 | Substantially Equivalent |
| K832942 | TOTAL & DIRECT BILIRUBIN PROCEDURES | Nov 7, 1983 | Substantially Equivalent |
| K832632 | ALBUMIN PROCEDURE BCP | Sep 12, 1983 | Substantially Equivalent |
| K832183 | SANDARE CALCIUM PROCEDURE | Aug 24, 1983 | Substantially Equivalent |