The following data is part of a premarket notification filed by Ind Diagnostic Inc. with the FDA for One Step Hcg Pregnancy Test - 2000 Miu/ml, Model 100 Series..
| Device ID | K052694 |
| 510k Number | K052694 |
| Device Name: | ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | IND DIAGNOSTIC INC. 1629 FOSTERS WAY Delta, Bc, CA V3m 6s7 |
| Contact | Jason Peng |
| Correspondent | Jason Peng IND DIAGNOSTIC INC. 1629 FOSTERS WAY Delta, Bc, CA V3m 6s7 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-28 |
| Decision Date | 2005-12-16 |