The following data is part of a premarket notification filed by Aniara Diagnostica ,llc with the FDA for Hemoclot Quanti- V-l, Factor V-l Calibrator, Biophen V-l Cal (undiluted), Biophen Act. Pc-r Control Plasma And Biophen.
| Device ID | K083729 |
| 510k Number | K083729 |
| Device Name: | HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN |
| Classification | Test, Time, Partial Thromboplastin |
| Applicant | ANIARA DIAGNOSTICA ,LLC 6560 GOVE COURT Mason, OH 45040 |
| Contact | Ola Anderson |
| Correspondent | Ola Anderson ANIARA DIAGNOSTICA ,LLC 6560 GOVE COURT Mason, OH 45040 |
| Product Code | GGW |
| Subsequent Product Code | GGN |
| Subsequent Product Code | JIT |
| CFR Regulation Number | 864.7925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-16 |
| Decision Date | 2009-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03663537019074 | K083729 | 000 |
| 03663537008320 | K083729 | 000 |