The following data is part of a premarket notification filed by Diagnostica Stago, Inc. with the FDA for Sta - Control La 1+2.
| Device ID | K061803 |
| 510k Number | K061803 |
| Device Name: | STA - CONTROL LA 1+2 |
| Classification | Control, Plasma, Abnormal |
| Applicant | DIAGNOSTICA STAGO, INC. 5 CENTURY DR. Parsippany, NJ 07054 |
| Contact | Laura Worfolk |
| Correspondent | Laura Worfolk DIAGNOSTICA STAGO, INC. 5 CENTURY DR. Parsippany, NJ 07054 |
| Product Code | GGC |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-27 |
| Decision Date | 2006-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607450002010 | K061803 | 000 |