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FDA 510(k)

IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT

K-Number: K863868 · 1987-02-13

ApplicantCooper Biomedical, Inc.
Decision Date1987-02-13
Product CodeDFF
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT 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 1987-02-13 under 510(k) number K863868. The device is classified under product code DFF. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT?

IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT is a medical device that received FDA 510(k) clearance on 1987-02-13. The listed applicant is Cooper Biomedical, Inc.. The 510(k) number is K863868.

When did IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT receive FDA 510(k) clearance?

IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT received FDA 510(k) clearance on 1987-02-13, under 510(k) number K863868.

Who is the listed applicant for IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT?

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 IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT?

The FDA product code for IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/ALPHA-1 ANT is DFF.

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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.

K864512IMMUNO-PLATE IV RADIAL IMMUNO TEST KIT/HUMAN HAPTOK863301DEMAND TOTAL PROTEINK861926WORTHINGTON HDL PRECIPITATING REAGENT SETK854130DEMAND ETHYL ALCOHOLK853949DEMAND ACID PHOSPHATASE REAGENTK852262ASSIST CLINICAL CHEMISTRY ANALYZER

View all 19 devices →

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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