The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys Hcg Test System.
| Device ID | K002148 |
| 510k Number | K002148 |
| Device Name: | ELECSYS HCG TEST SYSTEM |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | Priscilla A Hamill |
| Correspondent | Priscilla A Hamill ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-17 |
| Decision Date | 2000-08-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04015630940417 | K002148 | 000 |
| 04015630919383 | K002148 | 000 |