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FDA 510(k)

DV TEST AND DVV CONFIRM

K-Number: K940490 · 1995-04-05

ApplicantAmerican Diagnostica, Inc.
Decision Date1995-04-05
Product CodeGIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DV TEST AND DVV CONFIRM is the device name listed in this FDA 510(k) record. The listed applicant is American Diagnostica, Inc.. It received FDA 510(k) clearance on 1995-04-05 under 510(k) number K940490. The device is classified under product code GIR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DV TEST AND DVV CONFIRM?

DV TEST AND DVV CONFIRM is a medical device that received FDA 510(k) clearance on 1995-04-05. The listed applicant is American Diagnostica, Inc.. The 510(k) number is K940490.

When did DV TEST AND DVV CONFIRM receive FDA 510(k) clearance?

DV TEST AND DVV CONFIRM received FDA 510(k) clearance on 1995-04-05, under 510(k) number K940490.

Who is the listed applicant for DV TEST AND DVV CONFIRM?

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

What is the FDA product code for DV TEST AND DVV CONFIRM?

The FDA product code for DV TEST AND DVV CONFIRM is GIR.

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Other records listing American Diagnostica, Inc. as applicant

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Related Devices (Code: GIR)

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.

K110031HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRMInstrumentation Laboratory COK083878LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LAR2 Diagnostics, Inc.K061805STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRMDiagnostica Stago, Inc.K000527ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094Sigma Diagnostics, Inc.K000528ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119Sigma Diagnostics, Inc.K990580CRYOCHECK LA SURE, MODEL SUR25-10Precision Biologic

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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