K842327 is an FDA 510(k) clearance for the AMER. HISTO-ID SYS PRIMARY IGM S7920-31. This device is classified as a Igm, Antigen, Antiserum, Control (Class II - Special Controls, product code DFT).
Submitted by Bartels Immunodiagnostic Supplies, Inc. (Walker, US). The FDA issued a Cleared decision on August 2, 1984, 50 days after receiving the submission on June 13, 1984.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5550.
| 510(k) Number | K842327 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 1984 |
| Decision Date | August 02, 1984 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DFT — Igm, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5550 |