Lumi-Aggregometer
FDA 510(k) K771198 · Chrono-Log Corp.
510(k) numberK771198
Submission
- Device name
- Lumi-Aggregometer
- Applicant
- Chrono-Log Corp.
Havertown, PA, US - Received
- July 1, 1977
- Decision date
- August 2, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JBY – Aggregometer, Platelet, Photo-Optical Scanning
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.6675
- Specialty
- Hematology
Other 510(k)s with product code JBY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K912201 | PACKS-4 (TM) AnalyzerJBY · Traditional | Helena Laboratories | 08/16/1991SE |
More from Helena Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K161329 | Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelJOZ · Special | 12/02/2016SE |
| K050265 | Chrono-Log Whole Blood Lumi-Aggregometer, Model 700JOZ · Traditional | 10/14/2005SE |
| K032951 | Chrono-Log Whole Blood Aggregometer, Models 591A and 592AJOZ · Traditional | 04/02/2004SE |
| K962426 | Chrono-Log Whole Blood Aggregometer (Wba) 591/592JOZ · Traditional | 10/22/1996SE |
| K945414 | Ristocetin Cofactor Assay KitGGP · Traditional | 01/11/1995SE |
| K940792 | Aggro/Link VW Cofactor SoftwareJOZ · Traditional | 10/13/1994SE |
| K932566 | Aggro/Link Control SoftwareJBX · Traditional | 11/02/1993SE |
| K922800 | Platelet Aggregation ReagentsGHR · Traditional | 08/26/1992SE |
| K851025 | Aggro/Link Computer InterfaceJBX · Traditional | 06/12/1985SE |
| K850592 | Platelet Aggregation ReagentJBX · Traditional | 05/13/1985SE |
Questions and answers
When was Lumi-Aggregometer cleared by the FDA?
Lumi-Aggregometer (K771198) received a 510(k) decision of Substantially Equivalent on August 2, 1977, 32 days after the submission was received.
What is the product code of K771198?
The FDA product code is JBY – Aggregometer, Platelet, Photo-Optical Scanning, a Class II (moderate risk) device regulated under 21 CFR 864.6675.