Submission Details
| 510(k) Number | K936060 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 20, 1993 |
| Decision Date | September 06, 1994 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
ATOMSPEC GF BLOOD LEAD WORKSTATION
Sep 1994
Decision
260d
Days
Class 2
Risk
About This 510(k) Submission
K936060 is an FDA 510(k) clearance for the ATOMSPEC GF BLOOD LEAD WORKSTATION, a Lead, Atomic Absorption (Class II — Special Controls, product code DOF), submitted by Thermo Jarrell Ash Corp.Div.Thermo Inst. (Franklin, US). The FDA issued a Cleared decision on September 6, 1994, 260 days after receiving the submission on December 20, 1993. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3550.
Device Classification
| Product Code | DOF — Lead, Atomic Absorption |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3550 |
Manufacturer
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