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FDA 510(k)

LEAP MONO TEST KIT

K-Number: K840822 · 1984-04-05

ApplicantCooper Biomedical, Inc.
Decision Date1984-04-05
Product CodeKTN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

LEAP MONO 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 1984-04-05 under 510(k) number K840822. The device is classified under product code KTN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEAP MONO TEST KIT?

LEAP MONO TEST KIT is a medical device that received FDA 510(k) clearance on 1984-04-05. The listed applicant is Cooper Biomedical, Inc.. The 510(k) number is K840822.

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

LEAP MONO TEST KIT received FDA 510(k) clearance on 1984-04-05, under 510(k) number K840822.

Who is the listed applicant for LEAP MONO 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 MONO TEST KIT?

The FDA product code for LEAP MONO TEST KIT is KTN.

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: KTN)

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.

K181436OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid TestSEKISUI Diagnostics, LLCK042272ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)ACON Laboratories, Inc.K030215BIORAPID MONONUCLEOSISInstrumentation Laboratory COK012901COLOR-MONOGENInstrumentation Laboratory COK982634DRYSPOT INFECTIOUS MONONUCLEOSIS KITOxoid , Ltd.K981946CLEARVIEW IMUnipath , Ltd.

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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