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FDA 510(k)

A.QC HCT LEVEL 1 AND 2

K-Number: K893562 · 1989-07-14

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1989-07-14
Product CodeGLK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

A.QC HCT LEVEL 1 AND 2 is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1989-07-14 under 510(k) number K893562. The device is classified under product code GLK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the A.QC HCT LEVEL 1 AND 2?

A.QC HCT LEVEL 1 AND 2 is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K893562.

When did A.QC HCT LEVEL 1 AND 2 receive FDA 510(k) clearance?

A.QC HCT LEVEL 1 AND 2 received FDA 510(k) clearance on 1989-07-14, under 510(k) number K893562.

Who is the listed applicant for A.QC HCT LEVEL 1 AND 2?

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

What is the FDA product code for A.QC HCT LEVEL 1 AND 2?

The FDA product code for A.QC HCT LEVEL 1 AND 2 is GLK.

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Other records listing Johnson & Johnson Professionals, Inc. as applicant

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Related Devices (Code: GLK)

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.

K121467EUROTROL HEMATOCRIT CONTROLEurotrol B.V.K021924MEDICA EASYQC HEMATOCRIT CONTROLBionostics, Inc.K020618AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROLAalto Scientific, Ltd.K964452HEMATACHEKRichmond Diagnostics, Inc.K961807CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4Ciba Corning Diagnostics Corp.K924926MSI-HCTMedical Specialties, Inc.

Official Source

View on FDA Database →

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

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