510(k) K832791
- Device
- SERAYZER ALT/SGPT REAGENT STRIPS
- Applicant
- MILES LABORATORIES, INC.
- 510(k) number
- K832791
- Product code
- CKC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-10-14
- Date received
- 1983-08-19
- Regulation
- 862.1030
- Classification name
- Vanillin Pyruvate, Alt/sgpt
- 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
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CKC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K780507 | SERUM GLUTAMIC-PYRUVIC TRANSAMINASE | Gamma Enterprises, Inc. | 1978-05-03 |
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