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FDA 510(k)

STATSPIN STATSAMPLER

K-Number: K896206 · 1989-11-22

ApplicantStatspin Technologies
Decision Date1989-11-22
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STATSPIN STATSAMPLER is the device name listed in this FDA 510(k) record. The listed applicant is Statspin Technologies. It received FDA 510(k) clearance on 1989-11-22 under 510(k) number K896206. 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 STATSPIN STATSAMPLER?

STATSPIN STATSAMPLER is a medical device that received FDA 510(k) clearance on 1989-11-22. The listed applicant is Statspin Technologies. The 510(k) number is K896206.

When did STATSPIN STATSAMPLER receive FDA 510(k) clearance?

STATSPIN STATSAMPLER received FDA 510(k) clearance on 1989-11-22, under 510(k) number K896206.

Who is the listed applicant for STATSPIN STATSAMPLER?

The FDA 510(k) record lists Statspin Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STATSPIN STATSAMPLER?

The FDA product code for STATSPIN STATSAMPLER is JKA.

Related Clinical Trials

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Other records listing Statspin Technologies 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.

K903698STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBESK893613STATSPIN MINI-PLASMAK884807LIPOCLEAR LIPEMIA CLEARING REAGENT

Related Devices (Code: JKA)

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.

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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.

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