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FDA 510(k)

STAPHYLOCOCCI/STREPTOCOCCI SUPPLEMENT

K-Number: K800258 · 1980-03-12

ApplicantOxoid U.S.A., Inc.
Decision Date1980-03-12
Product CodeJSK
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STAPHYLOCOCCI/STREPTOCOCCI SUPPLEMENT 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 1980-03-12 under 510(k) number K800258. 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 STAPHYLOCOCCI/STREPTOCOCCI SUPPLEMENT?

STAPHYLOCOCCI/STREPTOCOCCI SUPPLEMENT is a medical device that received FDA 510(k) clearance on 1980-03-12. The listed applicant is Oxoid U.S.A., Inc.. The 510(k) number is K800258.

When did STAPHYLOCOCCI/STREPTOCOCCI SUPPLEMENT receive FDA 510(k) clearance?

STAPHYLOCOCCI/STREPTOCOCCI SUPPLEMENT received FDA 510(k) clearance on 1980-03-12, under 510(k) number K800258.

Who is the listed applicant for STAPHYLOCOCCI/STREPTOCOCCI SUPPLEMENT?

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 STAPHYLOCOCCI/STREPTOCOCCI SUPPLEMENT?

The FDA product code for STAPHYLOCOCCI/STREPTOCOCCI SUPPLEMENT 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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