510(k) K871499
- Device
- PROTOFLUOR Z
- Applicant
- Helena Laboratories
- 510(k) number
- K871499
- Product code
- JKJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-08-25
- Date received
- 1987-04-16
- Regulation
- 862.1595
- Classification name
- Fluorometric Measurement, Porphyrins
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAT FRANK
- Address
- 1530 Lindbergh Dr. P.O. Box 752 Beaumont TX US 77704 77704
FDA Registration Numbers#
- 3003951180
- 1618982
- 1644474
Source Documents#
510(k) summary PDF not indicated by FDA