The following data is part of a premarket notification filed by Itc, Inc. with the FDA for Hemochron Jr. Citrate Aptt Cuvette.
| Device ID | K014008 |
| 510k Number | K014008 |
| Device Name: | HEMOCHRON JR. CITRATE APTT CUVETTE |
| Classification | Activated Partial Thromboplastin |
| Applicant | ITC, INC. 8 OLSEN AVE. Edison, NJ 08820 |
| Contact | John Clay |
| Correspondent | John Clay ITC, INC. 8 OLSEN AVE. Edison, NJ 08820 |
| Product Code | GFO |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-05 |
| Decision Date | 2002-01-24 |
| Summary: | summary |