The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Architect Syphilis Tp Reagent, Architect Syphilis Tp Calibrator, Architect Syphilis Tp Control.
| Device ID | K153730 |
| 510k Number | K153730 |
| Device Name: | ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | Abbott Laboratories Dept 09AA, Bldg. AP 8, 100 Abbott Park Road Abbott Park, IL 60064 -6038 |
| Contact | Laura Yelvigi Joglekar |
| Correspondent | Laura Yelvigi Joglekar Abbott Laboratories Dept 09AA, Bldg. AP 8, 100 Abbott Park Road Abbott Park, IL 60064 -6038 |
| Product Code | LIP |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-28 |
| Decision Date | 2016-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740138196 | K153730 | 000 |
| 00380740117122 | K153730 | 000 |
| 00380740117115 | K153730 | 000 |
| 00380740103545 | K153730 | 000 |
| 00380740103538 | K153730 | 000 |
| 00380740138332 | K153730 | 000 |