The following data is part of a premarket notification filed by Chembio Diagnostic Systems, Inc. with the FDA for Hcg Stat-pak.
| Device ID | K923925 |
| 510k Number | K923925 |
| Device Name: | HCG STAT-PAK |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | Chembio Diagnostic Systems, Inc. 3661 HORSEBLOCK RD. Medford, NY 11763 |
| Contact | Paul C Reiter |
| Correspondent | Paul C Reiter Chembio Diagnostic Systems, Inc. 3661 HORSEBLOCK RD. Medford, NY 11763 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-05 |
| Decision Date | 1992-12-24 |