Panels › Hematology › Product code GHR · Class 2
Reagent, Platelet Aggregation
Regulation 864.5700
0510(k)s in 12 months (11 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in GHR
| Company | 510(k)s | Recalls |
|---|---|---|
| Helena Laboratories | 6 | 2 |
| Chrono-Log Corp. | 3 | 0 |
| Medical Diagnostic Technologies, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 23, 2007 | K061991 | PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA Helena Laboratories | GHR |
| Sep 8, 1995 | K952252 | ADP REAGENT, MODIFIED Helena Laboratories | GHR |
| Aug 26, 1992 | K922800 | PLATELET AGGREGATION REAGENTS Chrono-Log Corp. | GHR |
| May 20, 1991 | K910800 | ADP REAGENT Helena Laboratories | GHR |
| May 20, 1991 | K910706 | COLLAGEN REAGENT CAT. NO. 5368 Helena Laboratories | GHR |
| May 20, 1991 | K910680 | EPINEPHRINE REAGENT, CAT. NO. 5367 Helena Laboratories | GHR |
| Mar 19, 1991 | K910286 | PLATELET AGGREGATION REAGENTS Medical Diagnostic Technologies, Inc. | GHR |
| Mar 27, 1990 | K900792 | RISTOCETIN Medical Diagnostic Technologies, Inc. | GHR |
| Oct 20, 1983 | K832428 | PLATELET AGGREGATION REAGENT SET Helena Laboratories | GHR |
| Mar 16, 1982 | K820422 | PLATELET AGGREGOMETERS Chrono-Log Corp. | GHR |
| Jul 19, 1976 | K760198 | KIT, PLATELET AGGREGATION REAGENT (#390) Chrono-Log Corp. | GHR |
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