510(k) K843382
- Device
- UROCYSTIN
- Applicant
- MISSION PHARMACAL CO.
- 510(k) number
- K843382
- Product code
- JLC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-01-08
- Date received
- 1984-08-28
- 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#
- Contact
- GEORGE ALEXANDRIDES
- Address
- P.O. Box 1676 San Antonio TX US 78296 78296
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 |
|---|---|---|---|
| K810514 | SANDARE NITROPRUSSIDE TEST PROCEDURE | Sandare Chemical Co., Inc. | 1981-03-04 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases