The following data is part of a premarket notification filed by Thermo Jarrell Ash Corp.div.thermo Inst. with the FDA for Atomspec Gf Blood Lead Workstation.
Device ID | K936060 |
510k Number | K936060 |
Device Name: | ATOMSPEC GF BLOOD LEAD WORKSTATION |
Classification | Lead, Atomic Absorption |
Applicant | THERMO JARRELL ASH CORP.DIV.THERMO INST. 8E FORGE PKWY. Franklin, MA 02038 |
Contact | Zack Moseley |
Correspondent | Zack Moseley THERMO JARRELL ASH CORP.DIV.THERMO INST. 8E FORGE PKWY. Franklin, MA 02038 |
Product Code | DOF |
CFR Regulation Number | 862.3550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-20 |
Decision Date | 1994-09-06 |