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FDA 510(k)

MULTIPLE (IZON DNA BLOOD COLLECTION KIT)

K-Number: K010328 · 2001-04-09

ApplicantIzon Business Products, Inc.
Decision Date2001-04-09
Product CodePJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MULTIPLE (IZON DNA BLOOD COLLECTION KIT) is the device name listed in this FDA 510(k) record. The listed applicant is Izon Business Products, Inc.. It received FDA 510(k) clearance on 2001-04-09 under 510(k) number K010328. The device is classified under product code PJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTIPLE (IZON DNA BLOOD COLLECTION KIT)?

MULTIPLE (IZON DNA BLOOD COLLECTION KIT) is a medical device that received FDA 510(k) clearance on 2001-04-09. The listed applicant is Izon Business Products, Inc.. The 510(k) number is K010328.

When did MULTIPLE (IZON DNA BLOOD COLLECTION KIT) receive FDA 510(k) clearance?

MULTIPLE (IZON DNA BLOOD COLLECTION KIT) received FDA 510(k) clearance on 2001-04-09, under 510(k) number K010328.

Who is the listed applicant for MULTIPLE (IZON DNA BLOOD COLLECTION KIT)?

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

What is the FDA product code for MULTIPLE (IZON DNA BLOOD COLLECTION KIT)?

The FDA product code for MULTIPLE (IZON DNA BLOOD COLLECTION KIT) is PJE.

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 Izon Business Products, 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.

K950257MULTIPLE (IZON DBS & URINE COLLECTION KIT)K950221MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)K950246MULTIPLE (IZON URINE COLLECTION KIT)

Related Devices (Code: PJE)

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.

K231469PAXgene® Blood DNA TubePreanalytix GmbHK042927VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBESGreiner Bio-One Vacuette North AmericaK031359S-MONOVETTE EDTA K2-GELSarstedt, Inc.K014104VACUETTE EDTA K2 TUBESGreiner Vacuette North America, Inc.K012043VACUETTE EDTA K2 GEL TUBESGreiner Vacuette North America, Inc.K972075VACUTAINER BRAND PPT PLASMA PREPARATION TUBEBecton Dickinson Vacutainer Systems

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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