510(k) K901463
- Device
- REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO)
- Applicant
- HELENA LABORATORIES
- 510(k) number
- K901463
- Product code
- JQJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-06-12
- Date received
- 1990-03-28
- Regulation
- 862.1630
- Classification name
- Densitometeric, Protein Fractionation
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ERIC PETERSEN
- Address
- 1530 Lindbergh Dr. P.O. Box 752 Beaumont TX US 77704 77704
FDA Registration Numbers#
- 3008517993
- 1644474
- 8023024
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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