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FDA 510(k)

SELECTO-DISC NOVOBIOCIN 5UG

K-Number: K833407 · 1983-12-30

ApplicantLab Ability, Inc.
Decision Date1983-12-30
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SELECTO-DISC NOVOBIOCIN 5UG 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 1983-12-30 under 510(k) number K833407. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SELECTO-DISC NOVOBIOCIN 5UG?

SELECTO-DISC NOVOBIOCIN 5UG is a medical device that received FDA 510(k) clearance on 1983-12-30. The listed applicant is Lab Ability, Inc.. The 510(k) number is K833407.

When did SELECTO-DISC NOVOBIOCIN 5UG receive FDA 510(k) clearance?

SELECTO-DISC NOVOBIOCIN 5UG received FDA 510(k) clearance on 1983-12-30, under 510(k) number K833407.

Who is the listed applicant for SELECTO-DISC NOVOBIOCIN 5UG?

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 SELECTO-DISC NOVOBIOCIN 5UG?

The FDA product code for SELECTO-DISC NOVOBIOCIN 5UG is JTO.

Related Clinical Trials

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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.

K832436SELECTRO-DISCK830133Q-CHECK CULTI-LOOPSK830134Q-CHECK REAGENT STANDARDSK813191SHIGELLA SERA-CHEK

Related Devices (Code: JTO)

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.

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLCK970832PYR SWABRemel, Inc.K970834GRAM SWABRemel, Inc.K970833INDOLE SWABRemel, Inc.K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINMicrobiologics, Inc.K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic Systems, Inc.

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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