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FDA 510(k)

LYME FAST TEST

K-Number: K883544 · 1989-01-13

Applicant3M Company
Decision Date1989-01-13
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LYME FAST 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 1989-01-13 under 510(k) number K883544. 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 LYME FAST TEST?

LYME FAST TEST is a medical device that received FDA 510(k) clearance on 1989-01-13. The listed applicant is 3M Company. The 510(k) number is K883544.

When did LYME FAST TEST receive FDA 510(k) clearance?

LYME FAST TEST received FDA 510(k) clearance on 1989-01-13, under 510(k) number K883544.

Who is the listed applicant for LYME FAST 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 LYME FAST TEST?

The FDA product code for LYME FAST TEST is LSR.

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.

View all 322 devices →

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

View on FDA Database →

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

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