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FDA 510(k)

LEWIS BLOOD GROUP SUBSTANCE

K-Number: K771487 · 1977-11-08

ApplicantOrtho Diagnostics, Inc.
Decision Date1977-11-08
Product CodeKSX
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

LEWIS BLOOD GROUP SUBSTANCE 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 1977-11-08 under 510(k) number K771487. The device is classified under product code KSX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEWIS BLOOD GROUP SUBSTANCE?

LEWIS BLOOD GROUP SUBSTANCE is a medical device that received FDA 510(k) clearance on 1977-11-08. The listed applicant is Ortho Diagnostics, Inc.. The 510(k) number is K771487.

When did LEWIS BLOOD GROUP SUBSTANCE receive FDA 510(k) clearance?

LEWIS BLOOD GROUP SUBSTANCE received FDA 510(k) clearance on 1977-11-08, under 510(k) number K771487.

Who is the listed applicant for LEWIS BLOOD GROUP SUBSTANCE?

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 LEWIS BLOOD GROUP SUBSTANCE?

The FDA product code for LEWIS BLOOD GROUP SUBSTANCE is KSX.

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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: KSX)

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.

K802534GAMMA PI BLOOD GROUP SUBSTANCEGamma Biologicals, Inc.K802533GAMMA LEWIS BLOOD GROUP SUBSTANCEGamma Biologicals, Inc.K800916P1 BLOOD GROUP SUBSTANCETravenol Laboratories, S.A.K781862BLOOD GROUP SUBSTANCE ANorth American Biologicals, Inc.K781896BLOOD GROUP SUBSTANCE A,BNorth American Biologicals, Inc.K781895BLOOD GROUP SUBSTANCE BNorth American Biologicals, 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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