510(k) K061991
- Device
- PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
- Applicant
- HELENA LABORATORIES
- 510(k) number
- K061991
- Product code
- GHR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-02-23
- Date received
- 2006-07-13
- Regulation
- 864.5700
- Classification name
- Reagent, Platelet Aggregation
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PATRICIA FRANKS
- Address
- P.O. Box 752 1530 Lindbergh Dr. Beaumont TX US 77704 77704
FDA Registration Numbers#
- 1618982
- 2518152
- 2245451
- 3008386529
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GHR #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K952252 | ADP REAGENT, MODIFIED | Helena Laboratories | 1995-09-08 |
| K922800 | PLATELET AGGREGATION REAGENTS | Chrono-Log Corp. | 1992-08-26 |
| K910680 | EPINEPHRINE REAGENT, CAT. NO. 5367 | Helena Laboratories | 1991-05-20 |
| K910706 | COLLAGEN REAGENT CAT. NO. 5368 | Helena Laboratories | 1991-05-20 |
| K910800 | ADP REAGENT | Helena Laboratories | 1991-05-20 |
| K910286 | PLATELET AGGREGATION REAGENTS | Medical Diagnostic Technologies, Inc. | 1991-03-19 |
| K900792 | RISTOCETIN | Medical Diagnostic Technologies, Inc. | 1990-03-27 |
| K832428 | PLATELET AGGREGATION REAGENT SET | Helena Laboratories | 1983-10-20 |
| K820422 | PLATELET AGGREGOMETERS | Chrono-Log Corp. | 1982-03-16 |
| K760198 | KIT, PLATELET AGGREGATION REAGENT (#390) | Chrono-Log Corp. | 1976-07-19 |
Legacy Summary#
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FDA Review#
Decision Summary