PLATELET AGGREGOMETERS
FDA 510(k) clearance K820422 · decided 1982-03-16
Clearance details
- K-number
- K820422
- Device name
- PLATELET AGGREGOMETERS
- Applicant
- Chrono-Log Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-02-16
- Decision date
- 1982-03-16
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- GHR
- Device class
- 2
- Regulation number
- 864.5700
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA (K061991) | Helena Laboratories | 2007-02-23 |
| ADP REAGENT, MODIFIED (K952252) | Helena Laboratories | 1995-09-08 |
| PLATELET AGGREGATION REAGENTS (K922800) | Chrono-Log Corp. | 1992-08-26 |
| ADP REAGENT (K910800) | Helena Laboratories | 1991-05-20 |
| COLLAGEN REAGENT CAT. NO. 5368 (K910706) | Helena Laboratories | 1991-05-20 |
| EPINEPHRINE REAGENT, CAT. NO. 5367 (K910680) | Helena Laboratories | 1991-05-20 |
| PLATELET AGGREGATION REAGENTS (K910286) | Medical Diagnostic Technologies, Inc. | 1991-03-19 |
| RISTOCETIN (K900792) | Medical Diagnostic Technologies, Inc. | 1990-03-27 |
| PLATELET AGGREGATION REAGENT SET (K832428) | Helena Laboratories | 1983-10-20 |
| KIT, PLATELET AGGREGATION REAGENT (#390) (K760198) | Chrono-Log Corp. | 1976-07-19 |
Recalls involving this device
No recalls on record reference this clearance.