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FDA 510(k)

Q-CHECK CULTI-LOOPS

K-Number: K830133 · 1983-02-09

ApplicantLab Ability, Inc.
Decision Date1983-02-09
Product CodeJTR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Q-CHECK CULTI-LOOPS 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 1983-02-09 under 510(k) number K830133. The device is classified under product code JTR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Q-CHECK CULTI-LOOPS?

Q-CHECK CULTI-LOOPS is a medical device that received FDA 510(k) clearance on 1983-02-09. The listed applicant is Lab Ability, Inc.. The 510(k) number is K830133.

When did Q-CHECK CULTI-LOOPS receive FDA 510(k) clearance?

Q-CHECK CULTI-LOOPS received FDA 510(k) clearance on 1983-02-09, under 510(k) number K830133.

Who is the listed applicant for Q-CHECK CULTI-LOOPS?

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 CULTI-LOOPS?

The FDA product code for Q-CHECK CULTI-LOOPS is JTR.

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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-DISCK830134Q-CHECK REAGENT STANDARDSK813191SHIGELLA SERA-CHEK

Related Devices (Code: JTR)

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.

K871121PROTECT T.M.Pro-Lab, Inc.K862914FEKAL CHECK PARASITOLOGY CONTROL SLIDETrend Scientific, Inc.K861022KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMSMicro-Bio-LogicsK855198INDI KWIK (TM) CO/TWO KITMicro-Bio-LogicsK842579B.E.C. GROWTH CHEK MICROBIAL SUSPENSIONSBiological & Environmental Control LaboratoriesK842129LYFO-DISK MICROORGANISMSMicro-Bio-Logics

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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