The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Gps Platelet Separation Kit With Anticoagulant Acd-a.
| Device ID | K030555 |
| 510k Number | K030555 |
| Device Name: | GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A |
| Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Applicant | BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Lonnie Witham |
| Correspondent | Lonnie Witham BIOMET, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | JQC |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-21 |
| Decision Date | 2003-04-11 |
| Summary: | summary |