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FDA 510(k)

REAGENT CONFIDENCE SERA

K-Number: K771814 · 1977-11-07

ApplicantOrtho Diagnostics, Inc.
Decision Date1977-11-07
Product CodeKSF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

REAGENT CONFIDENCE SERA 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 1977-11-07 under 510(k) number K771814. The device is classified under product code KSF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENT CONFIDENCE SERA?

REAGENT CONFIDENCE SERA is a medical device that received FDA 510(k) clearance on 1977-11-07. The listed applicant is Ortho Diagnostics, Inc.. The 510(k) number is K771814.

When did REAGENT CONFIDENCE SERA receive FDA 510(k) clearance?

REAGENT CONFIDENCE SERA received FDA 510(k) clearance on 1977-11-07, under 510(k) number K771814.

Who is the listed applicant for REAGENT CONFIDENCE SERA?

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 REAGENT CONFIDENCE SERA?

The FDA product code for REAGENT CONFIDENCE SERA is KSF.

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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: KSF)

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.

K811713AVI-D CONTROLOrtho Diagnostic Systems, Inc.K810599DADE RH CONTROL REAGENTAmerican DadeK801425RH CONTROLNorth American Biologicals, Inc.K800658RST-SERIES CONTROLGamma Biologicals, Inc.K800310ORTHO ANTISERA CONTROLOrtho Diagnostics, Inc.K800239RH-HR NEGATIVE CONTROL REAGENTGotham Biologics, 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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