510(k) K842516
- Device
- SANDARE ACID PHOSPHATASE PROCEDURE
- Applicant
- SANDARE CHEMICAL CO., INC.
- 510(k) number
- K842516
- Product code
- CJR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-08-17
- Date received
- 1984-07-10
- Regulation
- 862.1020
- Classification name
- Acid Phosphatase, Thymol Blue Monophosphate
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CJR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K760161 | TEST, ACID PHOSPHATASE | Princeton Biomedix | 1976-07-20 |
Legacy Summary#
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FDA Review#
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