510(k) K780455
- Device
- Quantitative Determination Of Porphyrins
- Applicant
- WHALE SCIENTIFIC, INC.
- 510(k) number
- K780455
- Product code
- JKJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-07-27
- Date received
- 1978-03-20
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3003951180
- 1618982
- 1644474
Source Documents#
510(k) summary PDF not indicated by FDA