The following data is part of a premarket notification filed by Crestat Diagnostics, Inc. with the FDA for N-assay Tia Igm.
| Device ID | K933970 |
| 510k Number | K933970 |
| Device Name: | N-ASSAY TIA IGM |
| Classification | Method, Nephelometric, Immunoglobulins (g, A, M) |
| Applicant | CRESTAT DIAGNOSTICS, INC. 822 HAMPSHIRE RD. UNIT C Thousand Oaks, CA 91361 |
| Contact | Mary Rees |
| Correspondent | Mary Rees CRESTAT DIAGNOSTICS, INC. 822 HAMPSHIRE RD. UNIT C Thousand Oaks, CA 91361 |
| Product Code | CFN |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-13 |
| Decision Date | 1994-03-22 |