K781335 is an FDA 510(k) clearance for the DIGOXIN RIA (PEG) KIT. This device is classified as a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Polyethylene Glycol (Class II - Special Controls, product code DOG).
Submitted by Ortho Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1978, 29 days after receiving the submission on August 2, 1978.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.3320.
| 510(k) Number | K781335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 02, 1978 |
| Decision Date | August 31, 1978 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DOG — Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Polyethylene Glycol |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3320 |