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FDA 510(k)

STATSPIN MINI-PLASMA

K-Number: K893613 · 1989-08-28

ApplicantStatspin Technologies
Decision Date1989-08-28
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

STATSPIN MINI-PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Statspin Technologies. It received FDA 510(k) clearance on 1989-08-28 under 510(k) number K893613. 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 MINI-PLASMA?

STATSPIN MINI-PLASMA is a medical device that received FDA 510(k) clearance on 1989-08-28. The listed applicant is Statspin Technologies. The 510(k) number is K893613.

When did STATSPIN MINI-PLASMA receive FDA 510(k) clearance?

STATSPIN MINI-PLASMA received FDA 510(k) clearance on 1989-08-28, under 510(k) number K893613.

Who is the listed applicant for STATSPIN MINI-PLASMA?

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 MINI-PLASMA?

The FDA product code for STATSPIN MINI-PLASMA is JKA.

Related Clinical Trials

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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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 TUBESK896206STATSPIN STATSAMPLERK884807LIPOCLEAR 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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