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FDA 510(k)

SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS

K-Number: K012975 · 2002-02-28

ApplicantAbbott Laboratories
Decision Date2002-02-28
Product CodeNBW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2002-02-28 under 510(k) number K012975. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS?

SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS is a medical device that received FDA 510(k) clearance on 2002-02-28. The listed applicant is Abbott Laboratories. The 510(k) number is K012975.

When did SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS receive FDA 510(k) clearance?

SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS received FDA 510(k) clearance on 2002-02-28, under 510(k) number K012975.

Who is the listed applicant for SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS?

The FDA 510(k) record lists Abbott Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS?

The FDA product code for SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS is NBW. This falls under the OB/GYN category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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