AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2

Calibrator, Multi-analyte Mixture

ABBOTT LABORATORIES

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Amm Cal, Bil Cal, Co2 Cal, Hdl Cal, Iron/mg Cal, Ldl Cal, Mc Cal, Upro Cal, And Ise Calibrator Levels 1 And 2.

Pre-market Notification Details

• Device ID: K981706
• 510k Number: K981706
• Device Name: AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2
• Classification: Calibrator, Multi-analyte Mixture
• Applicant: ABBOTT LABORATORIES 1920 HURD DR. Irving, TX 75038
• Contact: Mark Littlefield
• Correspondent: Mark Littlefield; ABBOTT LABORATORIES 1920 HURD DR. Irving, TX 75038
• Product Code: JIX
• CFR Regulation Number: 862.1150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-05-14
• Decision Date: 1998-07-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00380740000479	K981706	000
00380740000462	K981706	000
00380740000448	K981706	000
00380740000417	K981706	000