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FDA 510(k)

BBL STAPHYSLIDE TEST

K-Number: K821962 · 1982-07-30

ApplicantBd Becton Dickinson Vacutainer Systems Preanalytic
Decision Date1982-07-30
Product CodeJWX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BBL STAPHYSLIDE TEST is the device name listed in this FDA 510(k) record. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. It received FDA 510(k) clearance on 1982-07-30 under 510(k) number K821962. The device is classified under product code JWX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BBL STAPHYSLIDE TEST?

BBL STAPHYSLIDE TEST is a medical device that received FDA 510(k) clearance on 1982-07-30. The listed applicant is Bd Becton Dickinson Vacutainer Systems Preanalytic. The 510(k) number is K821962.

When did BBL STAPHYSLIDE TEST receive FDA 510(k) clearance?

BBL STAPHYSLIDE TEST received FDA 510(k) clearance on 1982-07-30, under 510(k) number K821962.

Who is the listed applicant for BBL STAPHYSLIDE TEST?

The FDA 510(k) record lists Bd Becton Dickinson Vacutainer Systems Preanalytic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BBL STAPHYSLIDE TEST?

The FDA product code for BBL STAPHYSLIDE TEST is JWX.

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Other records listing Bd Becton Dickinson Vacutainer Systems Preanalytic as applicant

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Related Devices (Code: JWX)

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.

K090964BINAXNOX STAPHYLOCOCCUS AUREUS TESTBinax, Inc.K972030STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUSOxoid , Ltd.K964315REMEL STAPH LATEX KITRemel, L.P.K945538STAPHAUREX PLUS(TM)Murex Diagnostics LimitdK926173STAPH-A-LEX(TM) SYSTEMTrinity Laboratories, Inc.K923212SLIDEX STAPH-KITBiomerieux Vitek, 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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