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FDA 510(k)

BAC-T-SCREEN

K-Number: K833917 · 1984-01-13

ApplicantMarion Laboratories, Inc.
Decision Date1984-01-13
Product CodeJTA
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BAC-T-SCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Marion Laboratories, Inc.. It received FDA 510(k) clearance on 1984-01-13 under 510(k) number K833917. The device is classified under product code JTA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAC-T-SCREEN?

BAC-T-SCREEN is a medical device that received FDA 510(k) clearance on 1984-01-13. The listed applicant is Marion Laboratories, Inc.. The 510(k) number is K833917.

When did BAC-T-SCREEN receive FDA 510(k) clearance?

BAC-T-SCREEN received FDA 510(k) clearance on 1984-01-13, under 510(k) number K833917.

Who is the listed applicant for BAC-T-SCREEN?

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

What is the FDA product code for BAC-T-SCREEN?

The FDA product code for BAC-T-SCREEN is JTA.

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Other records listing Marion Laboratories, 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.

K883391POLYMER ADHESIVE BANDAGEK875182MODIFIED LABELING FOR TOXI-LAB THC SCREENK875181MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUMK874554ENVICLUSIVE (TM)K874552ENVISAN PADK874551ENVINET(TM)

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Related Devices (Code: JTA)

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.

K954923BACTEC FUNGAL MEDIUMBecton Dickinson Diagnostic Instrument SystemsK910835BACTEC NR-860Bd Becton Dickinson Vacutainer Systems PreanalyticK865021BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEMBd Becton Dickinson Vacutainer Systems PreanalyticK853011BACTEC NR-730 BACTERIAL DETECTION SYSTEMBd Becton Dickinson Vacutainer Systems PreanalyticK842874RADIOMETRIC BLOOD CULTURE VIALS, AEROBEAmerican Micro ScanK842279BECTEC NR-660 BACTERIAL DETECT SYSBd Becton Dickinson Vacutainer Systems Preanalytic

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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