510(k) K823127
- Device
- Advance Emit-cad Procainamide/n-acetyl
- Applicant
- SYVA CO.
- 510(k) number
- K823127
- Product code
- LAZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-11-29
- Date received
- 1982-10-25
- Regulation
- 862.3280
- Classification name
- N-Acetylprocainamide Control Materials
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- 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 LAZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K211667 | Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) | Changzhou Universal Medical Equipment Co., Ltd. | 2021-09-23 |
| K851474 | VYGON SPINAL ANESTHESIA TRAY CODE NO. 190 | Vygon Corp. | 1985-05-07 |
| K811461 | EMIT-AND METHOTREXATE CONTROL | Syva Co. | 1981-06-09 |