The following data is part of a premarket notification filed by Casco Standards with the FDA for Document Serum Multianalyte Calibration Verification Test Set.
| Device ID | K950469 |
| 510k Number | K950469 |
| Device Name: | DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SET |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | CASCO STANDARDS P.O. BOX 970 Yarmouth, ME 04096 -1970 |
| Contact | Christine V Beach |
| Correspondent | Christine V Beach CASCO STANDARDS P.O. BOX 970 Yarmouth, ME 04096 -1970 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-03 |
| Decision Date | 1995-04-11 |