MAX-ACT
Activated Whole Blood Clotting Time
ARRAY MEDICAL, INC.
The following data is part of a premarket notification filed by Array Medical, Inc. with the FDA for Max-act.
Pre-market Notification Details
| Device ID | K983649 |
| 510k Number | K983649 |
| Device Name: | MAX-ACT |
| Classification | Activated Whole Blood Clotting Time |
| Applicant | ARRAY MEDICAL, INC. ONE HARVARD WAY, SUITE 5 HILLSBOROUGH CAMPUS Somerville, NJ 08876 |
| Contact | Michael F Corsello |
| Correspondent | Michael F Corsello ARRAY MEDICAL, INC. ONE HARVARD WAY, SUITE 5 HILLSBOROUGH CAMPUS Somerville, NJ 08876 |
| Product Code | JBP |
| CFR Regulation Number | 864.7140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-16 |
| Decision Date | 1998-12-11 |
| Summary: | summary |
Trademark Results [MAX-ACT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAX-ACT 76471254 2752757 Live/Registered |
Helena Laboratories Corporation 2002-11-18 |
 MAX-ACT 75563489 not registered Dead/Abandoned |
Array Medical, Inc. 1998-10-02 |
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