The following data is part of a premarket notification filed by Casco Standards with the FDA for Document(tm) Total And Direct Bilirubin Linearity.
| Device ID | K896522 |
| 510k Number | K896522 |
| Device Name: | DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | CASCO STANDARDS P.O. BOX 970 Yarmouth, ME 04096 -1970 |
| Contact | Thomas M Happe |
| Correspondent | Thomas M Happe 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 | 1989-11-15 |
| Decision Date | 1990-01-02 |