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FDA 510(k)

AVI-D CONTROL

K-Number: K811713 · 1981-10-23

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1981-10-23
Product CodeKSF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AVI-D CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1981-10-23 under 510(k) number K811713. 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 AVI-D CONTROL?

AVI-D CONTROL is a medical device that received FDA 510(k) clearance on 1981-10-23. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K811713.

When did AVI-D CONTROL receive FDA 510(k) clearance?

AVI-D CONTROL received FDA 510(k) clearance on 1981-10-23, under 510(k) number K811713.

Who is the listed applicant for AVI-D CONTROL?

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

What is the FDA product code for AVI-D CONTROL?

The FDA product code for AVI-D CONTROL is KSF.

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Other records listing Ortho Diagnostic Systems, 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.

K951459ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATEK951632ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)K964754ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATEK963902QUANTITATIVE FIBRINOGEN ASSAYK950625ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)K950568ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)

View all 126 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.

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.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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