510(k) K912201
- Device
- PACKS-4 (TM) ANALYZER
- Applicant
- HELENA LABORATORIES
- 510(k) number
- K912201
- Product code
- JBY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-08-16
- Date received
- 1991-05-20
- Regulation
- 864.6675
- Classification name
- Aggregometer, Platelet, Photo-optical Scanning
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAT FRANKS
- Address
- 1530 Lindbergh Dr. P.O. Box 752 Beaumont TX US 77704 77704
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JBY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K771198 | LUMI-AGGREGOMETER | Chrono-Log Corp. | 1977-08-02 |
Legacy Summary#
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FDA Review#
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