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FDA 510(k)

LEAP STREP TEST KIT

K-Number: K833738 · 1983-12-27

ApplicantCooper Biomedical, Inc.
Decision Date1983-12-27
Product CodeGTP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LEAP STREP TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Cooper Biomedical, Inc.. It received FDA 510(k) clearance on 1983-12-27 under 510(k) number K833738. The device is classified under product code GTP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEAP STREP TEST KIT?

LEAP STREP TEST KIT is a medical device that received FDA 510(k) clearance on 1983-12-27. The listed applicant is Cooper Biomedical, Inc.. The 510(k) number is K833738.

When did LEAP STREP TEST KIT receive FDA 510(k) clearance?

LEAP STREP TEST KIT received FDA 510(k) clearance on 1983-12-27, under 510(k) number K833738.

Who is the listed applicant for LEAP STREP TEST KIT?

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

What is the FDA product code for LEAP STREP TEST KIT?

The FDA product code for LEAP STREP TEST KIT is GTP.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Cooper Biomedical, 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.

K863868IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANTK864512IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTOK863301DEMAND TOTAL PROTEINK861926WORTHINGTON HDL PRECIPITATING REAGENT SETK854130DEMAND ETHYL ALCOHOLK853949DEMAND ACID PHOSPHATASE REAGENT

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Related Devices (Code: GTP)

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.

K860041STREP D FLUORBio Spec, Inc.K822799STREPTACOCCUS CO-AGGLUTINATION KITAmerican Scientific Products

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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