The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Lipase-ps Assay Procedure No. 805.
| Device ID | K941085 |
| 510k Number | K941085 |
| Device Name: | LIPASE-PS ASSAY PROCEDURE NO. 805 |
| Classification | Lipase-esterase, Enzymatic, Photometric, Lipase |
| Applicant | SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | William Gilbert, Ph.d |
| Correspondent | William Gilbert, Ph.d SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | CHI |
| CFR Regulation Number | 862.1465 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-08 |
| Decision Date | 1994-05-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516742276 | K941085 | 000 |