The following data is part of a premarket notification filed by Esa Biosciences Inc. with the FDA for Esa Biosciences Inc. Vitamin D Hplc Test.
| Device ID | K072536 |
| 510k Number | K072536 |
| Device Name: | ESA BIOSCIENCES INC. VITAMIN D HPLC TEST |
| Classification | System, Test, Vitamin D |
| Applicant | ESA BIOSCIENCES INC. 22 ALPHA RD. Chelmsford, MA 01824 -4171 |
| Contact | Harold Asp |
| Correspondent | Harold Asp ESA BIOSCIENCES INC. 22 ALPHA RD. Chelmsford, MA 01824 -4171 |
| Product Code | MRG |
| CFR Regulation Number | 862.1825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-07 |
| Decision Date | 2008-05-07 |
| Summary: | summary |