The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Sigma Procedure No. 735.
| Device ID | K897147 |
| 510k Number | K897147 |
| Device Name: | SIGMA PROCEDURE NO. 735 |
| Classification | Acid, Lactic, Enzymatic Method |
| Applicant | SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178 |
| Contact | Leo Bressler |
| Correspondent | Leo Bressler SIGMA DIAGNOSTICS, INC. P.O. BOX 14508 St. Louis, MO 63178 |
| Product Code | KHP |
| CFR Regulation Number | 862.1450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-26 |
| Decision Date | 1990-04-03 |