The following data is part of a premarket notification filed by Ind Diagnostic Inc. with the FDA for One Step Fsh Menopausal Test.
| Device ID | K052662 |
| 510k Number | K052662 |
| Device Name: | ONE STEP FSH MENOPAUSAL TEST |
| Classification | Radioimmunoassay, Follicle-stimulating Hormone |
| Applicant | IND DIAGNOSTIC INC. 1629 FOSTERS WAY Delta, B.c., CA V3m 6s7 |
| Contact | Jason Peng |
| Correspondent | Jason Peng IND DIAGNOSTIC INC. 1629 FOSTERS WAY Delta, B.c., CA V3m 6s7 |
| Product Code | CGJ |
| CFR Regulation Number | 862.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-27 |
| Decision Date | 2005-11-30 |