510(k) K873426
- Device
- Easy-test Emit(r) Amikacin (amik) No. 16645
- Applicant
- EM DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K873426
- Product code
- KLP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-10-29
- Date received
- 1987-08-25
- Regulation
- 862.3035
- Classification name
- Amikacin Serum Assay
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RAYMOND L MILLER
- Address
- 480 Democrat Rd. Gibbstown NJ US 08027 08027
FDA Registration Numbers#
- 3006198300
- 3003795116
- 9610126
- 9610529
Source Documents#
510(k) summary PDF not indicated by FDA