The following data is part of a premarket notification filed by Avl Scientific Corp. with the FDA for Ref. Electrode Sol'n.;standard B.
| Device ID | K821885 |
| 510k Number | K821885 |
| Device Name: | REF. ELECTRODE SOL'N.;STANDARD B |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | AVL SCIENTIFIC CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-25 |
| Decision Date | 1982-07-13 |