The following data is part of a premarket notification filed by Diagnostica Stago, Inc. with the FDA for Sta-quality Hbpm/lmwh Kit.
| Device ID | K010324 |
| 510k Number | K010324 |
| Device Name: | STA-QUALITY HBPM/LMWH KIT |
| Classification | Plasma, Coagulation Control |
| Applicant | DIAGNOSTICA STAGO, INC. 5 CENTURY DR. Parsippany, NJ 07054 |
| Contact | Andrew Loc B. Le |
| Correspondent | Andrew Loc B. Le 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 | 2001-02-02 |
| Decision Date | 2001-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607450006865 | K010324 | 000 |