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FDA 510(k)

LYME STAT M TEST KIT

K-Number: K904652 · 1991-10-21

ApplicantWhittaker Bioproducts, Inc.
Decision Date1991-10-21
Product CodeLSR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LYME STAT M TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Whittaker Bioproducts, Inc.. It received FDA 510(k) clearance on 1991-10-21 under 510(k) number K904652. 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 STAT M TEST KIT?

LYME STAT M TEST KIT is a medical device that received FDA 510(k) clearance on 1991-10-21. The listed applicant is Whittaker Bioproducts, Inc.. The 510(k) number is K904652.

When did LYME STAT M TEST KIT receive FDA 510(k) clearance?

LYME STAT M TEST KIT received FDA 510(k) clearance on 1991-10-21, under 510(k) number K904652.

Who is the listed applicant for LYME STAT M TEST KIT?

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

What is the FDA product code for LYME STAT M TEST KIT?

The FDA product code for LYME STAT M TEST KIT is LSR.

Other records listing Whittaker Bioproducts, 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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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.

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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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