The following data is part of a premarket notification filed by Syva Co. with the FDA for Emit(r) Thc 50/100 Ng Assay.
| Device ID | K932716 |
| 510k Number | K932716 |
| Device Name: | EMIT(R) THC 50/100 NG ASSAY |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | SYVA CO. 3403 YERBA BUENA RD. San Jose, CA 95135 -1500 |
| Contact | Rogers, Jr. |
| Correspondent | Rogers, Jr. SYVA CO. 3403 YERBA BUENA RD. San Jose, CA 95135 -1500 |
| Product Code | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-04 |
| Decision Date | 1993-10-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768023910 | K932716 | 000 |
| 00842768002151 | K932716 | 000 |