The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Immunalysis Carisoprodol Metabolite / Meprobamate Urine Heia.
| Device ID | K190397 |
| 510k Number | K190397 |
| Device Name: | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA |
| Classification | Meprobamate Test System |
| Applicant | Immunalysis Corporation 829 Towne Center Drive Pomona, CA 91767 |
| Contact | Yang Yang |
| Correspondent | Yang Yang Immunalysis Corporation 829 Towne Center Drive Pomona, CA 91767 |
| Product Code | QBK |
| CFR Regulation Number | 862.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-19 |
| Decision Date | 2019-11-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840937110294 | K190397 | 000 |
| 00840937110287 | K190397 | 000 |
| 00840937110270 | K190397 | 000 |
| 00840937110263 | K190397 | 000 |