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

FDA 510(k) clearance K981706 · decided 1998-07-09

Clearance details

K-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

Applicant

Abbott Laboratories

Decision

Substantially Equivalent

Date received

1998-05-14

Decision date

1998-07-09

Days to decision

56 days

Clearance type

Traditional

Product code

JIX

Device class

2

Regulation number

862.1150

Medical specialty

Clinical Chemistry

Advisory committee

Clinical Chemistry

Location

Irving, TX, US

Third-party review

No

Expedited review

No

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