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FDA 510(k)

3M IGG FASTLYME(TM) TEST

K-Number: K895713 · 1990-12-14

Applicant3M Company
Decision Date1990-12-14
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

3M IGG FASTLYME(TM) TEST is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company. It received FDA 510(k) clearance on 1990-12-14 under 510(k) number K895713. The device is classified under product code LSR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3M IGG FASTLYME(TM) TEST?

3M IGG FASTLYME(TM) TEST is a medical device that received FDA 510(k) clearance on 1990-12-14. The listed applicant is 3M Company. The 510(k) number is K895713.

When did 3M IGG FASTLYME(TM) TEST receive FDA 510(k) clearance?

3M IGG FASTLYME(TM) TEST received FDA 510(k) clearance on 1990-12-14, under 510(k) number K895713.

Who is the listed applicant for 3M IGG FASTLYME(TM) TEST?

The FDA 510(k) record lists 3M Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M IGG FASTLYME(TM) TEST?

The FDA product code for 3M IGG FASTLYME(TM) TEST is LSR.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing 3M Company as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LSR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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