The following data is part of a premarket notification filed by Fisher Scientific Co., Llc. with the FDA for Fisher Diagnostics Kda Calibrator I.
| Device ID | K851150 |
| 510k Number | K851150 |
| Device Name: | FISHER DIAGNOSTICS KDA CALIBRATOR I |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | FISHER SCIENTIFIC CO., LLC. 526 ROUTE 303 Orangeburg, NY 10962 |
| Contact | Charles B Breuer |
| Correspondent | Charles B Breuer FISHER SCIENTIFIC CO., LLC. 526 ROUTE 303 Orangeburg, NY 10962 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-21 |
| Decision Date | 1985-05-20 |