510(k) K932566
- Device
- AGGRO/LINK CONTROL SOFTWARE
- Applicant
- CHRONO-LOG CORP.
- 510(k) number
- K932566
- Product code
- JBX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-11-02
- Date received
- 1993-05-27
- Regulation
- 864.6675
- Classification name
- Aggregrometer, Platelet
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ARTHUR FREILICH
- Address
- 2 W. Park Rd. Havertown PA US 19083 19083
FDA Registration Numbers#
- 1618982
- 2518152
- 2245451
- 9710666
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JBX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K912774 | ARACHIDONIC ACID | Helena Laboratories | 1991-08-22 |
| K881829 | PAT PLATELET AGGREGATION TEST | Streck Laboratories, Inc. | 1988-07-01 |
| K862775 | ASSERACHROM B-TG KIT | American Bioproducts Co. | 1986-10-22 |
| K851025 | AGGRO/LINK COMPUTER INTERFACE | Chrono-Log Corp. | 1985-06-12 |
| K850592 | PLATELET AGGREGATION REAGENT | Chrono-Log Corp. | 1985-05-13 |
| K832929 | RISTOCETIN PLATELET AGGREGA-REAGENT TEST | Sigma Chemical Co. | 1983-09-29 |
| K830749 | PLATELET AGGREGOMETER | Chrono-Log Corp. | 1983-05-16 |
| K821005 | PLATELET AGGREGATION PROFILER #PAP-4 | Bio/Data Corp. | 1982-06-01 |
| K811290 | ARACHIDONIC ACID | Bio/Data Corp. | 1981-07-27 |
| K781710 | BUFFER, COLLAGEN REAGENT AND DILUENT | Diagnostica, Inc. | 1978-10-24 |
| K760159 | AGGREGOMETER, DUAL CHANNEL PLATELET | Chrono-Log Corp. | 1976-07-20 |
Legacy Summary#
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FDA Review#
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