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FDA 510(k)

Q-CHECK REAGENT STANDARDS

K-Number: K830134 · 1983-01-09

ApplicantLab Ability, Inc.
Decision Date1983-01-09
Product CodeLJG
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Q-CHECK REAGENT STANDARDS 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 1983-01-09 under 510(k) number K830134. The device is classified under product code LJG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Q-CHECK REAGENT STANDARDS?

Q-CHECK REAGENT STANDARDS is a medical device that received FDA 510(k) clearance on 1983-01-09. The listed applicant is Lab Ability, Inc.. The 510(k) number is K830134.

When did Q-CHECK REAGENT STANDARDS receive FDA 510(k) clearance?

Q-CHECK REAGENT STANDARDS received FDA 510(k) clearance on 1983-01-09, under 510(k) number K830134.

Who is the listed applicant for Q-CHECK REAGENT STANDARDS?

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 Q-CHECK REAGENT STANDARDS?

The FDA product code for Q-CHECK REAGENT STANDARDS is LJG.

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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-LOOPSK813191SHIGELLA SERA-CHEK

Related Devices (Code: LJG)

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.

K943228MICROSPORIDIUM CONTROL SETMeridian Diagnostics, Inc.K924893MICROSPORIDIUM CONTROL SLIDEScientific Device Laboratory, Inc.K890670CRYPTOSPORIDIUM CONTROL SLIDEScientific Device Laboratory, Inc.K890718GRAM STAIN CONTROL SLIDEScientific Device Laboratory, Inc.K890616BION DIRECT IDENTIFICATION CONTROL SLIDEBion Ent., Ltd.K883570HISTO-CHECK FUNGAL CONTROL SLIDESVal Tech Diagnostics, Inc.

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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