Product code GHR— Hematology
PLATELET AGGREGATION REAGENTS
- Classification name
- Reagent, Platelet Aggregation
- Device class
- Class 2
- Regulation
- 21 CFR 864.5700
- Advisory panel
- Hematology
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code GHR
FDA has cleared devices under product code GHR between 1976 and 2007, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2007
- 1995
- 1992
- 1991
- 1990
- 1983
- 1982
- 1976
Top applicants under product code GHR
Recent clearances under product code GHR
- K061991 — PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
- K952252 — ADP REAGENT, MODIFIED
- K922800 — PLATELET AGGREGATION REAGENTS
- K910680 — EPINEPHRINE REAGENT, CAT. NO. 5367
- K910706 — COLLAGEN REAGENT CAT. NO. 5368
- K910800 — ADP REAGENT
- K910286 — PLATELET AGGREGATION REAGENTS
- K900792 — RISTOCETIN
- K832428 — PLATELET AGGREGATION REAGENT SET
- K820422 — PLATELET AGGREGOMETERS
- K760198 — KIT, PLATELET AGGREGATION REAGENT (#390)
Data sourced from openFDA. This site is unofficial and independent of the FDA.