The following data is part of a premarket notification filed by Atlas Medical with the FDA for Atlas Home Pregnancy Test (midstream Format) Model 70172001.
| Device ID | K102760 |
| 510k Number | K102760 |
| Device Name: | ATLAS HOME PREGNANCY TEST (MIDSTREAM FORMAT) MODEL 70172001 |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | ATLAS MEDICAL KING ABDULLAH II INDUS. ESTATE SAHAB FREE ZONE AREA, ST. #1 Amman, JO 11512 |
| Contact | Nour Al-ahwal |
| Correspondent | Nour Al-ahwal ATLAS MEDICAL KING ABDULLAH II INDUS. ESTATE SAHAB FREE ZONE AREA, ST. #1 Amman, JO 11512 |
| Product Code | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-23 |
| Decision Date | 2011-08-03 |
| Summary: | summary |