510(k) K810514
- Device
- SANDARE NITROPRUSSIDE TEST PROCEDURE
- Applicant
- SANDARE CHEMICAL CO., INC.
- 510(k) number
- K810514
- Product code
- JLC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-03-04
- Date received
- 1981-02-25
- Regulation
- 862.1240
- Classification name
- Nitroprusside Reaction (qualitative, Urine), Cystine
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3021841051
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JLC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K843382 | UROCYSTIN | Mission Pharmacal Co. | 1985-01-08 |
Legacy Summary#
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FDA Review#
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