510(k) K894327
- Device
- Emit D.a.u. Low & Medium Calibrator A
- Applicant
- SYVA CO.
- 510(k) number
- K894327
- Product code
- DKG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-08-03
- Date received
- 1989-07-14
- Regulation
- 862.2270
- Classification name
- Plate, Cellulose, Tlc
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROGERS, JR
- Address
- 900 Arastradero Rd. P.O. Box 10058 Palo Alto CA US 94303 94303
Source Documents#
510(k) summary PDF not indicated by FDA