The following data is part of a premarket notification filed by Diagnostica Stago, Inc. with the FDA for Sta- Coag Control (n+abn) Plus.
| Device ID | K120014 |
| 510k Number | K120014 |
| Device Name: | STA- COAG CONTROL (N+ABN) PLUS |
| Classification | Plasma, Coagulation Control |
| Applicant | DIAGNOSTICA STAGO, INC. 5 CENTURY DR. Parsippany, NJ 07054 |
| Contact | Kevin Wyckoff |
| Correspondent | Kevin Wyckoff DIAGNOSTICA STAGO, INC. 5 CENTURY DR. Parsippany, NJ 07054 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-29 |
| Decision Date | 2013-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607450006773 | K120014 | 000 |