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FDA 510(k)

STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM

K-Number: K061805 · 2006-12-06

ApplicantDiagnostica Stago, Inc.
Decision Date2006-12-06
Product CodeGIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostica Stago, Inc.. It received FDA 510(k) clearance on 2006-12-06 under 510(k) number K061805. 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 STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM?

STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM is a medical device that received FDA 510(k) clearance on 2006-12-06. The listed applicant is Diagnostica Stago, Inc.. The 510(k) number is K061805.

When did STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM receive FDA 510(k) clearance?

STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM received FDA 510(k) clearance on 2006-12-06, under 510(k) number K061805.

Who is the listed applicant for STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM?

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

What is the FDA product code for STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM?

The FDA product code for STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM is GIR.

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Other records listing Diagnostica Stago, Inc. as applicant

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K260214STA® - Liquid Anti-XaK253658STA Satellite Max®K120014STA- COAG CONTROL (N+ABN) PLUSK111822STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWHK092937STA-HYBRID HEP CALIBRATORK093167STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER

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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.K000527ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094Sigma Diagnostics, Inc.K000528ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119Sigma Diagnostics, Inc.K990580CRYOCHECK LA SURE, MODEL SUR25-10Precision BiologicK990579CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)Precision 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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