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FDA 510(k)

MICROSAMPLE BLOOD COLLECTION DEVICE

K-Number: K761137 · 1977-02-07

ApplicantOrtho Diagnostics, Inc.
Decision Date1977-02-07
Product CodeGKH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MICROSAMPLE BLOOD COLLECTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostics, Inc.. It received FDA 510(k) clearance on 1977-02-07 under 510(k) number K761137. The device is classified under product code GKH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROSAMPLE BLOOD COLLECTION DEVICE?

MICROSAMPLE BLOOD COLLECTION DEVICE is a medical device that received FDA 510(k) clearance on 1977-02-07. The listed applicant is Ortho Diagnostics, Inc.. The 510(k) number is K761137.

When did MICROSAMPLE BLOOD COLLECTION DEVICE receive FDA 510(k) clearance?

MICROSAMPLE BLOOD COLLECTION DEVICE received FDA 510(k) clearance on 1977-02-07, under 510(k) number K761137.

Who is the listed applicant for MICROSAMPLE BLOOD COLLECTION DEVICE?

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

What is the FDA product code for MICROSAMPLE BLOOD COLLECTION DEVICE?

The FDA product code for MICROSAMPLE BLOOD COLLECTION DEVICE is GKH.

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Other records listing Ortho Diagnostics, 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.

K802404ORTHO BOVINE ALBUMIN SOLUTION 30% PROTEK801507ANTIGEN CONTROL CELLSK800357BI-LEVEL ASSAYED CARD. DRUG CONT., I,IIK800310ORTHO ANTISERA CONTROLK791791ORTHO ANTIBODY ENHANCEMENT SOLUTIONK791301ORTHO TSH RIA KIT

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Related Devices (Code: GKH)

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.

K100684CELLTRACKS AUTOPREP SYSTEM MODEL:9541Veridex, LLCK040077IMMUNICON CELLTRACKS AUTOPREP SYSTEMImmunicon Corp.K022512CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518Immunicon Corp.K021150COULTER CELLPREPBeckman Coulter, Inc.K935953COULTER MULTI Q PREPCoulter Corp.K923530COULTER MULTI-Q-PREPCoulter Electronics, 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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