The following data is part of a premarket notification filed by Tosoh Bioscience, Inc. with the FDA for St Aia-pack Homocysteine; St Aia-pack Homocysteine Calibrator Set; Aia-pack Homocysteine Control Set.
| Device ID | K121533 |
| 510k Number | K121533 |
| Device Name: | ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET |
| Classification | Urinary Homocystine (nonquantitative) Test System |
| Applicant | Tosoh BioScience, Inc. 6000 SHORELINE COURT SUITE 101 South San Francisco, CA 94080 |
| Contact | Robert Wick |
| Correspondent | Robert Wick Tosoh BioScience, Inc. 6000 SHORELINE COURT SUITE 101 South San Francisco, CA 94080 |
| Product Code | LPS |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1377 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-24 |
| Decision Date | 2012-06-15 |
| Summary: | summary |