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FDA 510(k)

LYME-SPOT IF KIT

K-Number: K910230 · 1991-08-30

ApplicantVitek Systems, Inc.
Decision Date1991-08-30
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LYME-SPOT IF KIT is the device name listed in this FDA 510(k) record. The listed applicant is Vitek Systems, Inc.. It received FDA 510(k) clearance on 1991-08-30 under 510(k) number K910230. 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-SPOT IF KIT?

LYME-SPOT IF KIT is a medical device that received FDA 510(k) clearance on 1991-08-30. The listed applicant is Vitek Systems, Inc.. The 510(k) number is K910230.

When did LYME-SPOT IF KIT receive FDA 510(k) clearance?

LYME-SPOT IF KIT received FDA 510(k) clearance on 1991-08-30, under 510(k) number K910230.

Who is the listed applicant for LYME-SPOT IF KIT?

The FDA 510(k) record lists Vitek Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LYME-SPOT IF KIT?

The FDA product code for LYME-SPOT IF KIT is LSR.

Other records listing Vitek Systems, Inc. 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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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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