The following data is part of a premarket notification filed by Gold Standard Diagnostics with the FDA for Gold Standard Diagnostics Aix1000 Rapid Plasma Reagin (rpr) Automated Test System.
| Device ID | K150358 |
| 510k Number | K150358 |
| Device Name: | Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System |
| Classification | Antigens, Nontreponemal, All |
| Applicant | GOLD STANDARD DIAGNOSTICS 2851 SPAFFORD Davis, CA 95618 |
| Contact | Napoleon Monce |
| Correspondent | Napoleon Monce GOLD STANDARD DIAGNOSTICS 2851 SPAFFORD Davis, CA 95618 |
| Product Code | GMQ |
| CFR Regulation Number | 866.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-12 |
| Decision Date | 2015-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B350004000 | K150358 | 000 |
| B350GSD1600WCASE0 | K150358 | 000 |
| B350GSD051600W0 | K150358 | 000 |
| B350GSD051600PC0 | K150358 | 000 |
| B350GSD051600NC0 | K150358 | 000 |
| B350GSD011600DYE0 | K150358 | 000 |
| B35000400R0 | K150358 | 000 |
| B350GSD051600MW0 | K150358 | 000 |