510(k) K874705
- Device
- Easy-test Amylase (amyl), Item Number 19019
- Applicant
- EM DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K874705
- Product code
- JEJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-12-22
- Date received
- 1987-11-19
- Regulation
- 874.4680
- Classification name
- Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- RAYMOND L MILLER
- Address
- 480 Democrat Rd. Gibbstown NJ US 08027 08027
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JEJ
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K821514 | TECHNICON RA-1000 SYS, ANALYTES III | Technicon Instruments Corp. | 1982-05-10 |