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FDA 510(k)

SELECTRO-DISC

K-Number: K832436 · 1983-09-26

ApplicantLab Ability, Inc.
Decision Date1983-09-26
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SELECTRO-DISC 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 1983-09-26 under 510(k) number K832436. 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 SELECTRO-DISC?

SELECTRO-DISC is a medical device that received FDA 510(k) clearance on 1983-09-26. The listed applicant is Lab Ability, Inc.. The 510(k) number is K832436.

When did SELECTRO-DISC receive FDA 510(k) clearance?

SELECTRO-DISC received FDA 510(k) clearance on 1983-09-26, under 510(k) number K832436.

Who is the listed applicant for SELECTRO-DISC?

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 SELECTRO-DISC?

The FDA product code for SELECTRO-DISC is JTO.

Related Clinical Trials

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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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 5UGK830133Q-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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