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FDA 510(k)

SHIGELLA SERA-CHEK

K-Number: K813191 · 1981-12-03

ApplicantLab Ability, Inc.
Decision Date1981-12-03
Product CodeLIA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SHIGELLA SERA-CHEK is the device name listed in this FDA 510(k) record. The listed applicant is Lab Ability, Inc.. It received FDA 510(k) clearance on 1981-12-03 under 510(k) number K813191. The device is classified under product code LIA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHIGELLA SERA-CHEK?

SHIGELLA SERA-CHEK is a medical device that received FDA 510(k) clearance on 1981-12-03. The listed applicant is Lab Ability, Inc.. The 510(k) number is K813191.

When did SHIGELLA SERA-CHEK receive FDA 510(k) clearance?

SHIGELLA SERA-CHEK received FDA 510(k) clearance on 1981-12-03, under 510(k) number K813191.

Who is the listed applicant for SHIGELLA SERA-CHEK?

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

What is the FDA product code for SHIGELLA SERA-CHEK?

The FDA product code for SHIGELLA SERA-CHEK is LIA.

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Other records listing Lab Ability, 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.

K833407SELECTO-DISC NOVOBIOCIN 5UGK832436SELECTRO-DISCK830133Q-CHECK CULTI-LOOPSK830134Q-CHECK REAGENT STANDARDS

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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