The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Spermcheck Fertility.
Device ID | K100341 |
510k Number | K100341 |
Device Name: | SPERMCHECK FERTILITY |
Classification | Semen Analysis Device |
Applicant | PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
Contact | Kyung-ah Kim |
Correspondent | Kyung-ah Kim PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
Product Code | POV |
CFR Regulation Number | 864.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-02-05 |
Decision Date | 2010-05-04 |
Summary: | summary |