The following data is part of a premarket notification filed by Axis-shield Doc As with the FDA for Coatest(r) Apc(tm) Resistance.
| Device ID | K945940 |
| 510k Number | K945940 |
| Device Name: | COATEST(R) APC(TM) RESISTANCE |
| Classification | Test, Time, Partial Thromboplastin |
| Applicant | AXIS-SHIELD DOC AS P.O. BOX 262069 San Diego, CA 92196 -2069 |
| Contact | Ronald G Leonardi |
| Correspondent | Ronald G Leonardi AXIS-SHIELD DOC AS 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 | 1994-12-05 |
| Decision Date | 1995-08-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950088929 | K945940 | 000 |
| 08426950088912 | K945940 | 000 |
| 08426950060147 | K945940 | 000 |