The following data is part of a premarket notification filed by Array Medical, Inc. with the FDA for Actalyke Activated Clotting Time Test System/clotting Time Tubes/whole Blood Qc Kit/actalyke Electronic Clotting Tube.
| Device ID | K964609 |
| 510k Number | K964609 |
| Device Name: | ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE |
| Classification | Activated Whole Blood Clotting Time |
| Applicant | ARRAY MEDICAL, INC. 245 RT. 22 WEST Bridgewater, NJ 08807 |
| Contact | Patricia E Bonness |
| Correspondent | Patricia E Bonness ARRAY MEDICAL, INC. 245 RT. 22 WEST Bridgewater, NJ 08807 |
| Product Code | JBP |
| CFR Regulation Number | 864.7140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-18 |
| Decision Date | 1997-03-06 |
| Summary: | summary |