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FDA 510(k)

SDI PREPAX COUNTAPETTE KIT

K-Number: K892658 · 1989-05-24

Decision Date1989-05-24
Product CodeJCG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SDI PREPAX COUNTAPETTE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Distributors, Inc.. It received FDA 510(k) clearance on 1989-05-24 under 510(k) number K892658. The device is classified under product code JCG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SDI PREPAX COUNTAPETTE KIT?

SDI PREPAX COUNTAPETTE KIT is a medical device that received FDA 510(k) clearance on 1989-05-24. The listed applicant is Scientific Distributors, Inc.. The 510(k) number is K892658.

When did SDI PREPAX COUNTAPETTE KIT receive FDA 510(k) clearance?

SDI PREPAX COUNTAPETTE KIT received FDA 510(k) clearance on 1989-05-24, under 510(k) number K892658.

Who is the listed applicant for SDI PREPAX COUNTAPETTE KIT?

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

What is the FDA product code for SDI PREPAX COUNTAPETTE KIT?

The FDA product code for SDI PREPAX COUNTAPETTE KIT is JCG.

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.

Other records listing Scientific Distributors, 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.

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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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