PLATELET AGGREGATION REAGENT
FDA 510(k) clearance K850592 · decided 1985-05-13
Clearance details
- K-number
- K850592
- Device name
- PLATELET AGGREGATION REAGENT
- Applicant
- Chrono-Log Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-02-15
- Decision date
- 1985-05-13
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- JBX
- Device class
- 2
- Regulation number
- 864.6675
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Havertown, PA, 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 |
|---|---|---|
| AGGRO/LINK CONTROL SOFTWARE (K932566) | Chrono-Log Corp. | 1993-11-02 |
| ARACHIDONIC ACID (K912774) | Helena Laboratories | 1991-08-22 |
| PAT PLATELET AGGREGATION TEST (K881829) | Streck Laboratories, Inc. | 1988-07-01 |
| ASSERACHROM B-TG KIT (K862775) | American Bioproducts Co. | 1986-10-22 |
| AGGRO/LINK COMPUTER INTERFACE (K851025) | Chrono-Log Corp. | 1985-06-12 |
| RISTOCETIN PLATELET AGGREGA-REAGENT TEST (K832929) | Sigma Chemical Co. | 1983-09-29 |
| PLATELET AGGREGOMETER (K830749) | Chrono-Log Corp. | 1983-05-16 |
| PLATELET AGGREGATION PROFILER #PAP-4 (K821005) | Bio/Data Corp. | 1982-06-01 |
| ARACHIDONIC ACID (K811290) | Bio/Data Corp. | 1981-07-27 |
| BUFFER, COLLAGEN REAGENT AND DILUENT (K781710) | Diagnostica, Inc. | 1978-10-24 |
| AGGREGOMETER, DUAL CHANNEL PLATELET (K760159) | Chrono-Log Corp. | 1976-07-20 |
Recalls involving this device
No recalls on record reference this clearance.