The following data is part of a premarket notification filed by Equal Diagnostics, Inc. with the FDA for Sentinel Lipase Liquid Model 17.401b.
| Device ID | K961179 |
| 510k Number | K961179 |
| Device Name: | SENTINEL LIPASE LIQUID MODEL 17.401B |
| Classification | Lipase-esterase, Enzymatic, Photometric, Lipase |
| Applicant | EQUAL DIAGNOSTICS, INC. 115 SUMMIT DR. Exton, PA 19341 |
| Contact | Brenda Y Kan |
| Correspondent | Brenda Y Kan EQUAL DIAGNOSTICS, INC. 115 SUMMIT DR. Exton, PA 19341 |
| Product Code | CHI |
| CFR Regulation Number | 862.1465 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-26 |
| Decision Date | 1996-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08058056680617 | K961179 | 000 |