The following data is part of a premarket notification filed by Casco Standards with the FDA for Document(tm) Cholesterol Calibrator Set.
| Device ID | K884197 |
| 510k Number | K884197 |
| Device Name: | DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET |
| Classification | Calibrator, Secondary |
| 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 | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-06 |
| Decision Date | 1988-12-14 |