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FDA 510(k)

ORTHO ANTISERA CONTROL

K-Number: K800310 · 1980-03-05

ApplicantOrtho Diagnostics, Inc.
Decision Date1980-03-05
Product CodeKSF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ORTHO ANTISERA CONTROL 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 1980-03-05 under 510(k) number K800310. 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 ORTHO ANTISERA CONTROL?

ORTHO ANTISERA CONTROL is a medical device that received FDA 510(k) clearance on 1980-03-05. The listed applicant is Ortho Diagnostics, Inc.. The 510(k) number is K800310.

When did ORTHO ANTISERA CONTROL receive FDA 510(k) clearance?

ORTHO ANTISERA CONTROL received FDA 510(k) clearance on 1980-03-05, under 510(k) number K800310.

Who is the listed applicant for ORTHO ANTISERA CONTROL?

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 ORTHO ANTISERA CONTROL?

The FDA product code for ORTHO ANTISERA CONTROL 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,IIK791791ORTHO ANTIBODY ENHANCEMENT SOLUTIONK791301ORTHO TSH RIA KITK790813MULTECON BLOOD GAS CONTROL

View all 24 devices →

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.K800239RH-HR NEGATIVE CONTROL REAGENTGotham Biologics, Inc.K790249TEST CELLSHyland Therapeutic Div., Travenol Laboratories

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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