FDA 510(k)

FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM

K-Number: K851450 · 1985-09-16

Decision Date1985-09-16

Product CodeJIW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM is the device name listed in this FDA 510(k) record. The listed applicant is Flow Cytometry Standards Corp.. It received FDA 510(k) clearance on 1985-09-16 under 510(k) number K851450. The device is classified under product code JIW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM?

FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM is a medical device that received FDA 510(k) clearance on 1985-09-16. The listed applicant is Flow Cytometry Standards Corp.. The 510(k) number is K851450.

When did FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM receive FDA 510(k) clearance?

FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM received FDA 510(k) clearance on 1985-09-16, under 510(k) number K851450.

Who is the listed applicant for FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM?

The FDA 510(k) record lists Flow Cytometry Standards Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM?

The FDA product code for FLUORESCENT MICROBEAD ALIGNMENT STANDARDS TM is JIW.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.