The following data is part of a premarket notification filed by Diagnostica Stago, Inc. with the FDA for Asserachrom Hpia Test Kit.
| Device ID | K003767 |
| 510k Number | K003767 |
| Device Name: | ASSERACHROM HPIA TEST KIT |
| Classification | Platelet Factor 4 Radioimmunoassay |
| Applicant | DIAGNOSTICA STAGO, INC. FIVE CENTURY DR. Parsippany, NJ 07054 |
| Contact | Andrew Loc B Le |
| Correspondent | Andrew Loc B Le DIAGNOSTICA STAGO, INC. FIVE CENTURY DR. Parsippany, NJ 07054 |
| Product Code | LCO |
| CFR Regulation Number | 864.7695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-06 |
| Decision Date | 2001-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03607450006155 | K003767 | 000 |