Submission Details
| 510(k) Number | K810536 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 26, 1981 |
| Decision Date | March 17, 1981 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
K810536 is an FDA 510(k) clearance for the ZEEMAN/5000 GRAPHITE FURNACE ATOMIC ABSB, a Atomic Absorption Spectrophotometer, General Use (Class I — General Controls, product code JXR), submitted by The Perkin-Elmer Corp. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1981, 19 days after receiving the submission on February 26, 1981. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2850.
| 510(k) Number | K810536 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 26, 1981 |
| Decision Date | March 17, 1981 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | — |
| Product Code | JXR — Atomic Absorption Spectrophotometer, General Use |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.2850 |