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FDA 510(k)

LEGIONELLA CYE AGAR BASE & BCYE SUPPL

K-Number: K831469 · 1983-06-08

ApplicantOxoid U.S.A., Inc.
Decision Date1983-06-08
Product CodeJSK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LEGIONELLA CYE AGAR BASE & BCYE SUPPL is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid U.S.A., Inc.. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K831469. The device is classified under product code JSK. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEGIONELLA CYE AGAR BASE & BCYE SUPPL?

LEGIONELLA CYE AGAR BASE & BCYE SUPPL is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Oxoid U.S.A., Inc.. The 510(k) number is K831469.

When did LEGIONELLA CYE AGAR BASE & BCYE SUPPL receive FDA 510(k) clearance?

LEGIONELLA CYE AGAR BASE & BCYE SUPPL received FDA 510(k) clearance on 1983-06-08, under 510(k) number K831469.

Who is the listed applicant for LEGIONELLA CYE AGAR BASE & BCYE SUPPL?

The FDA 510(k) record lists Oxoid U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEGIONELLA CYE AGAR BASE & BCYE SUPPL?

The FDA product code for LEGIONELLA CYE AGAR BASE & BCYE SUPPL is JSK.

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Other records listing Oxoid U.S.A., 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.

K891593LISTERIA SELECTIVE ENRICHMENT MEDIUMK884026ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KITK884208LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)K874303STAPHYLASE TESTK872956SORBITOL MACCONKEY AGAR NO. 3 CM 813K872135MCBRIDE MEDIUM CM 819

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Related Devices (Code: JSK)

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.

K881949ATS NAC-PAC SETAlpha-Tec Systems, Inc.K881879ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42Alpha-Tec Systems, Inc.K881566HEMOGLOBIN POWDERAcumedia Manufacturers, Inc.K861997PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTUREHazleton Research Products, Inc.K861791PENICILLIN-STREPTOMYCIN-FUNGIZONEFlow Laboratories, Inc.K861824GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN)Flow Laboratories, 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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