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FDA 510(k)

LEGIONELLA, GROWTH & SELECTIVE, SUPP.

K-Number: K811516 · 1981-06-24

ApplicantOxoid U.S.A., Inc.
Decision Date1981-06-24
Product CodeJSK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LEGIONELLA, GROWTH & SELECTIVE, SUPP. 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 1981-06-24 under 510(k) number K811516. 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, GROWTH & SELECTIVE, SUPP.?

LEGIONELLA, GROWTH & SELECTIVE, SUPP. is a medical device that received FDA 510(k) clearance on 1981-06-24. The listed applicant is Oxoid U.S.A., Inc.. The 510(k) number is K811516.

When did LEGIONELLA, GROWTH & SELECTIVE, SUPP. receive FDA 510(k) clearance?

LEGIONELLA, GROWTH & SELECTIVE, SUPP. received FDA 510(k) clearance on 1981-06-24, under 510(k) number K811516.

Who is the listed applicant for LEGIONELLA, GROWTH & SELECTIVE, SUPP.?

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, GROWTH & SELECTIVE, SUPP.?

The FDA product code for LEGIONELLA, GROWTH & SELECTIVE, SUPP. 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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