The following data is part of a premarket notification filed by Chromogenix Ab with the FDA for Coatest Apc (tm) Resistance V/coatest Apc (tm) Resistance V S.
| Device ID | K963111 |
| 510k Number | K963111 |
| Device Name: | COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S |
| Classification | Test, Time, Partial Thromboplastin |
| Applicant | CHROMOGENIX AB P.O. BOX 262069 San Diego, CA 92196 -2069 |
| Contact | Ronald G Leonardi |
| Correspondent | Ronald G Leonardi CHROMOGENIX AB P.O. BOX 262069 San Diego, CA 92196 -2069 |
| Product Code | GGW |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-12 |
| Decision Date | 1996-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950087656 | K963111 | 000 |
| 08426950062424 | K963111 | 000 |
| 08426950060017 | K963111 | 000 |
| 08426950076100 | K963111 | 000 |