EMIT-AND METHOTREXATE CONTROL
FDA 510(k) clearance K811461 · decided 1981-06-09
Clearance details
- K-number
- K811461
- Device name
- EMIT-AND METHOTREXATE CONTROL
- Applicant
- Syva Co.
- Decision
- Substantially Equivalent
- Date received
- 1981-05-26
- Decision date
- 1981-06-09
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- LAZ
- Device class
- 1
- Regulation number
- 862.3280
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) (K211667) | Changzhou Universal Medical Equipment Co., Ltd. | 2021-09-23 |
| VYGON SPINAL ANESTHESIA TRAY CODE NO. 190 (K851474) | Vygon Corp. | 1985-05-07 |
| ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL (K823127) | Syva Co. | 1982-11-29 |
Recalls involving this device
No recalls on record reference this clearance.