510(k) K771198
- Device
- LUMI-AGGREGOMETER
- Applicant
- CHRONO-LOG CORP.
- 510(k) number
- K771198
- Product code
- JBY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-08-02
- Date received
- 1977-07-01
- Regulation
- 864.6675
- Classification name
- Aggregometer, Platelet, Photo-optical Scanning
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- Arthur Freilich
- Address
- 2 W. Park Rd. Havertown PA US 19083 19083
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JBY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K912201 | PACKS-4 (TM) ANALYZER | Helena Laboratories | 1991-08-16 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases