The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Assay, Amphet. Ndc#11711-0127-1 Coulter.
| Device ID | K760196 |
| 510k Number | K760196 |
| Device Name: | ASSAY, AMPHET. NDC#11711-0127-1 COULTER |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | COULTER ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-07-06 |
| Decision Date | 1976-08-03 |