510(k) K821514
- Device
- Technicon Ra-1000 Sys, Analytes Iii
- Applicant
- TECHNICON INSTRUMENTS CORP.
- 510(k) number
- K821514
- Product code
- JEJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-05-10
- Date received
- 1982-05-10
- 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
- N
Related Records
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 JEJ
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K874705 | EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019 | Em Diagnostic Systems, Inc. | 1987-12-22 |