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FDA 510(k)

RESUBMISSION OF THE KLEERZIT REAGENT

K-Number: K864866 · 1987-03-16

ApplicantAdvanced Biomedical Methods, Inc.
Decision Date1987-03-16
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RESUBMISSION OF THE KLEERZIT REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Biomedical Methods, Inc.. It received FDA 510(k) clearance on 1987-03-16 under 510(k) number K864866. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESUBMISSION OF THE KLEERZIT REAGENT?

RESUBMISSION OF THE KLEERZIT REAGENT is a medical device that received FDA 510(k) clearance on 1987-03-16. The listed applicant is Advanced Biomedical Methods, Inc.. The 510(k) number is K864866.

When did RESUBMISSION OF THE KLEERZIT REAGENT receive FDA 510(k) clearance?

RESUBMISSION OF THE KLEERZIT REAGENT received FDA 510(k) clearance on 1987-03-16, under 510(k) number K864866.

Who is the listed applicant for RESUBMISSION OF THE KLEERZIT REAGENT?

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

What is the FDA product code for RESUBMISSION OF THE KLEERZIT REAGENT?

The FDA product code for RESUBMISSION OF THE KLEERZIT REAGENT is JKA.

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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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