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FDA 510(k)

OXY-SWAB

K-Number: K831673 · 1983-06-30

ApplicantAustin Biological Laboratories
Decision Date1983-06-30
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OXY-SWAB is the device name listed in this FDA 510(k) record. The listed applicant is Austin Biological Laboratories. It received FDA 510(k) clearance on 1983-06-30 under 510(k) number K831673. 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 OXY-SWAB?

OXY-SWAB is a medical device that received FDA 510(k) clearance on 1983-06-30. The listed applicant is Austin Biological Laboratories. The 510(k) number is K831673.

When did OXY-SWAB receive FDA 510(k) clearance?

OXY-SWAB received FDA 510(k) clearance on 1983-06-30, under 510(k) number K831673.

Who is the listed applicant for OXY-SWAB?

The FDA 510(k) record lists Austin Biological Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OXY-SWAB?

The FDA product code for OXY-SWAB is JTO.

Other records listing Austin Biological Laboratories 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.

K880511XACT NEISSERIAK874727PRECEPT(TM) CIPROFLOXACINK870769AUSTIN NONFERMENTER KITK864069PRECEPT (TM) TICARCILLIN/CLAVULANIC ACIDK862560PRECEPT CEFTIZOXIMEK862446PRECEPT CEFTAZIDIME

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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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