FDA 510(k)

STREPTOCOCCUS SUPPLEMENT

K-Number: K800260 · 1980-03-12

Decision Date1980-03-12

Product CodeJSK

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

STREPTOCOCCUS 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 K800260. 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 STREPTOCOCCUS SUPPLEMENT?

STREPTOCOCCUS 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 K800260.

When did STREPTOCOCCUS SUPPLEMENT receive FDA 510(k) clearance?

STREPTOCOCCUS SUPPLEMENT received FDA 510(k) clearance on 1980-03-12, under 510(k) number K800260.

Who is the listed applicant for STREPTOCOCCUS 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 STREPTOCOCCUS SUPPLEMENT?

The FDA product code for STREPTOCOCCUS SUPPLEMENT is JSK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Oxoid U.S.A., Inc. as applicant

K891593LISTERIA SELECTIVE ENRICHMENT MEDIUM K884026ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT K884208LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)K874303STAPHYLASE TEST K872956SORBITOL MACCONKEY AGAR NO. 3 CM 813 K872135MCBRIDE MEDIUM CM 819

View all 93 devices →

Related Devices (Code: JSK)

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.