The following data is part of a premarket notification filed by Casco Standards with the FDA for Document(r) Zero.
| Device ID | K940568 |
| 510k Number | K940568 |
| Device Name: | DOCUMENT(R) ZERO |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | CASCO STANDARDS P.O BOX 970 Yarmouth, ME 04096 |
| Contact | Lenity Larrabee |
| Correspondent | Lenity Larrabee CASCO STANDARDS P.O BOX 970 Yarmouth, ME 04096 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-08 |
| Decision Date | 1994-04-05 |