K913212 is an FDA 510(k) clearance for the 3M IGE SINGLE POINT FAST TEST. This device is classified as a System, Test, Radioallergosorbent (rast) Immunological (Class II - Special Controls, product code DHB).
Submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on November 22, 1991, 126 days after receiving the submission on July 19, 1991.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5750.
| 510(k) Number | K913212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 1991 |
| Decision Date | November 22, 1991 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DHB — System, Test, Radioallergosorbent (rast) Immunological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5750 |